NewzIntel.com

Category: AM-NC

  • MIL-OSI USA: Deputy Administrator Isobel Coleman Meets with with Ukraine Minister of Finance Sergii Marchenko

    Source: USAID

    The below is attributable to Deputy Spokesperson Shejal Pulivarti:‎

    Today, Deputy Administrator Isobel Coleman met with Ukrainian Finance Minister Sergii Marchenko to reaffirm USAID’s commitment to helping Ukraine meet its urgent financing needs, including through the G7 loans announced this week. 

    Deputy Administrator Coleman and Minister Marchenko discussed the importance of continued reforms to improve Ukraine’s business climate, which are crucial for investment and long-term economic recovery. They also underscored their shared commitment to Ukraine’s transparency, customs reform, macroeconomic stability, and recovery efforts.

    MIL OSI USA News –

  • MIL-OSI USA: Joint Statement by FBI and CISA on PRC Activity Targeting Telecommunications

    News In Brief – Source: US Computer Emergency Readiness Team

    WASHINGTON: The U.S. Government is investigating the unauthorized access to commercial telecommunications infrastructure by actors affiliated with the People’s Republic of China. 

     After the FBI identified specific malicious activity targeting the sector, the FBI and the Cybersecurity and Infrastructure Security Agency (CISA) immediately notified affected companies, rendered technical assistance, and rapidly shared information to assist other potential victims. The investigation is ongoing, and we encourage any organization that believes it might be a victim to engage its local FBI field office or CISA. 

     Agencies across the U.S. Government are collaborating to aggressively mitigate this threat and are coordinating with our industry partners to strengthen cyber defenses across the commercial communications sector.

    ###

    MIL OSI USA News –

  • MIL-OSI USA: Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication

    Source: US Food and Drug Administration

    Español 简体中文 (Simplified Chinese) Tagalog

    Date Issued: October 25, 2024

    The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers (hereafter referred to simply as BioZorb Markers) by Hologic Inc.

    On October 25, 2024, Hologic announced a voluntary recall for removal of all lots of unused BioZorb Markers. The recall is due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue.

    The FDA is issuing this communication to help ensure you are aware of the manufacturer’s most recent recall notice and the recommended actions.

    Recommendations for Patients with a BioZorb Marker and their Caregivers

    • If you experience any adverse events with your BioZorb Marker, please contact your health care provider.
    • There is no need to have the device removed from your body (explanted) unless advised by your health care provider.
    • If your provider is planning radiation therapy treatments, discuss the possible risks with your provider. The FDA has not cleared or approved the use of BioZorb Marker as a marker for radiation treatment.
    • Report any problems or complications with your BioZorb Marker to the FDA.

    Recommendations for Health Care Providers and Facilities

    • Do not implant BioZorb Markers.
    • Quarantine and return all lots of unused BioZorb Markers to Hologic.
    • Review and discuss the Recommendations for Patients above with your patients who have a BioZorb Marker.
    • Be aware of reports of serious adverse events following the placement of BioZorb Marker devices in breast tissue.
    • Continue to monitor patients who have an implanted BioZorb Marker for signs of any adverse events.
    • Be aware the FDA has not cleared or approved the use of BioZorb Markers to fill space in the tissue or to improve cosmetic outcomes after procedures, or as a marker for radiation treatment.
    • Report any problems or complications your patients experience following the placement of BioZorb Marker devices to the FDA.

    Device Description

    BioZorb Markers are implantable devices used in soft tissue sites, including breast tissue. BioZorb Markers have two parts: a plastic component that is intended to be dissolved completely in the patient’s body in one year or longer, and a titanium metal component that is permanent.

    The BioZorb Marker is indicated for radiographic marking of sites in soft tissue. In addition, the BioZorb Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

    The BioZorb Marker is not indicated to improve cosmetic outcomes after procedures, fill space in the tissue, or to be a marker for radiation treatment.

    Risks Associated with BioZorb Marker in Breast Tissue

    Reported complications and adverse events with BioZorb Marker that include serious injuries are:

    • Pain
    • Infection
    • Rash
    • Device migration (moving out of position)
    • Device erosion (breaking through the skin)
    • Seroma (fluid buildup)
    • Discomfort
    • Other complications from feeling the device in the breast

    In some instances, additional medical treatment, including having the device removed from the body (explantation), was needed.

    FDA Actions

    The FDA will continue to work with Hologic to monitor reports of problems with BioZorb Markers, including issues that may develop over time.

    The FDA will continue to keep the public informed if significant new information becomes available.

    Unique Device Identifier

    The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

    You can find the UDI provided by Hologic, Inc. for BioZorb Marker and BioZorb LP Marker devices by checking the table below.

    Version or Model Device Brand Name Device Description Device Identifier (DI) Number
    F0405 BioZorb Bioadsorbable Marker BioZorb Marker 4cm x 5cm 15420045514065
    F0404 BioZorb Bioadsorbable Marker BioZorb Marker 4cm x 4cm 15420045514058
    F0304 BioZorb Bioadsorbable Marker BioZorb Marker 3cm x 4cm 15420045514010
    F0303 BioZorb Bioadsorbable Marker BioZorb Marker 3cm x 3cm 15420045514003
    F0203 BioZorb Bioadsorbable Marker BioZorb Marker 2cm x 3cm 15420045513990
    F0202 BioZorb Bioadsorbable Marker BioZorb Marker 2cm x 2cm 15420045513983
    F0331 BioZorb LP Bioadsorbable Marker BioZorb Marker 1cm x 3cm x 3cm 15420045514041
    F0231 BioZorb LP Bioadsorbable Marker BioZorb Marker 1cm x 3cm x 2cm 15420045514034
    F0221 BioZorb LP Bioadsorbable Marker BioZorb Marker 1cm x 3cm x 2cm 15420045514027

    Reporting Problems with Your Device

    If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

    Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

    Questions?

    If you have questions,

    MIL OSI USA News –

  • MIL-OSI USA: Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk

    Source: US Food and Drug Administration

    This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  

    Affected Product

    • Product Names: Jaco Assistive Robotic Arm 
    • Models: 
      • PJ 0000 0001
      • PJ 0000 0012
      • PJ 0090 0001
      • PJ 0090 0006
      • KR MJ2 0001 
    • Lot/Serial Numbers: All lots   

    What to Do

    • Inspect the Jaco Arm for missing parts or scratches, chips, cracks, nicks, or other visible damage to the outer coating of the arm. 
    • Unplug the Jaco arm from the power source if the wheelchair is in contact with a damaged part of the Jaco arm at any time during use. 
    • Contact Kinova Customer Service as soon as possible to have the wheelchair and arm installation assessed for this issue and for assistance with protective pad installation.

    On August 19, 2024, Kinova sent all affected customers an Urgent Medical Device Correction recommending the following actions: 

    For users

    • Contact Kinova Customer Service as soon as possible to arrange for an assessment by phone at 514-277-3777 ext. 2 or by email at support@kinova.ca.
    • Unplug the Jaco arm immediately if the wheelchair is in contact with a damaged part of the Jaco arm in any position at any time.
    • Read the updated user guide found on Kinova’s website.
      • Kinova will send a printed copy of this updated user guide to every user in September 2024.
    • Return the acknowledgement and receipt form attached to the letter and return by email to support@kinova.ca or by mail to: Kinova Customer Service, 4333 de la Grande Allee Boul., Boisbriand, Quebec, Canada J7H 1M7.

    For distributors

    • Share the Urgent Medical Device Correction notice with all Jaco arm users. 
    • Confirm to Kinova that the User Correction Notice was sent to all users.
    • Keep a detailed list of users, when they were contacted, and when they responded. 
      • Make three attempts using two different communication methods to contact users.
    • Provide user contact details (name, phone, email, address) to Kinova. This information will be used only to complete the field corrective action. 
    • Complete a video or in-person assessment for each user who responded to the notice to identify and mitigate the risk that electrical current could flow through the outer coating of the Jaco arm. Kinova will provide remote support for conducting these assessments and review the user and installation guides during each user’s assessment which will include: 
      • Assessing the robotic arm’s installation.
      • Reviewing the robotic arm for damage.
      • Assessing wheelchair integrity based on updated installation requirements.
    • Implement mitigations (i.e. protective pads) to minimize contact between the Jaco arm and other metallic parts and ensure that updated warnings and requirements are acknowledged.

    Reason for Correction

    Kinova is correcting the Jaco assistive robotic arm due to an increased fire hazard if the outer coating of the arm has any damage and makes contact with an electrically powered wheelchair that has electrical leakage from modifications, damage, or malfunction.

    The use of affected product may cause serious adverse health consequences, including burns, other thermal injuries, and death.

    There have been no reported injuries and no reports of death.

    Device Use

    The Jaco assistive robotic arm is intended for use by people who have lost most or all functionality of their arms. The arm replaces the function of one arm on a single side of the body by allowing the user to reach, move, and manipulate objects. It is designed to be installed on a motorized wheelchair and is controlled through the wheelchair’s drive control. 

    Contact Information

    Customers in the U.S. with questions about this recall should contact Kinova Customer Service at 514-277-3777 ext. 2 or by email at support@kinova.ca. 

    Additional FDA Resources

    Unique Device Identifier (UDI)

    The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

    How do I report a problem?

    Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

    MIL OSI USA News –

  • MIL-OSI USA: Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

    Source: US Food and Drug Administration

    Please be aware, the recall initiated in March 2024 is a correction, not a product removal.

    The FDA has identified the recall initiated in March 2024 as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    The recall initiated in October 2024 is a removal of all lots of unused BioZorb Markers.

    Recalled Product

    • Product Names: BioZorb Marker
    • Product Codes: NEU
    • Model Numbers:
      • F0405 BioZorb Marker 4cm x 5cm
      • F0404 BioZorb Marker 4cm x 4cm
      • F0331 BioZorb Marker 1cm x 3cm x 3cm
      • F0231 BioZorb Marker 1cm x 3cm x 2cm
      • F0221 BioZorb Marker 1cm x 3cm x 2cm
      • F0304 BioZorb Marker 3cm x 4cm
      • F0303 BioZorb Marker 3cm x 3cm
      • F0203 BioZorb Marker 2cm x 3cm
      • F0202 BioZorb Marker 2cm x 2cm
    • Distribution Dates: April 29, 2019 to April 1, 2024
    • Devices Recalled in the U.S.: 53,492
    • Date Initiated by Firm: March 13, 2024

    Device Use

    The BioZorb Marker made by Hologic (previously Focal Therapeutics), is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures, such as radiation. Device has two components: a permanent component which is made of titanium metal and a resorbable component which is made of a plastic material that resorbes over time. It’s provided sterile, meant for one-time use.

    Reason for Recall

    Hologic, Inc. is recalling Biozorb Marker due to complications and adverse events reported with implanted devices. Complaints included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device.

    There have been 71 reported injuries and no reports of death.

    Who May be Affected

    • People who were implanted with the BioZorb marker device.
    • People who receive radiation guided by the BioZorb marker which may have migrated.
    • People who receive systemic cancer treatments as treatments may be delayed due to complications with BioZorb Marker.
    • Radiologist, surgeons, oncologists and other health care providers who use BioZorb Marker for treatment of their patients.

    What to Do

    On March 13, 2024, Hologic, Inc. sent all affected customers an Important Medical Device Safety Notification.

    The letter requested patients to:

    • Contact their health care provider if they experience any adverse events following the placement of a BioZorb Marker.
    • Discuss the benefits and possible risks of implantable breast tissue markers for breast cancer procedures with their health care provider.
    • Report any problems or complications experienced following the placement of BioZorb Marker devices to Hologic at breasthealth.support@hologic.com and to the FDA’s MedWatch Adverse Event Reporting program.
    • Discuss the benefits and possible risks of implantable breast tissue markers for breast cancer procedures with their health care provider.

    The letter requested health care providers to:

    • Be aware of reports of serious adverse events following the placement of the BioZorb Marker devices in breast tissue.
    • Discuss the benefits and possible risks of BioZorb Marker devices with each patient.
    • Inform all patients on which device will be used if a marking device will be used during breast conservation surgery.
    • Continue to monitor patients who have an implanted BioZorb Marker for signs of any adverse events.
    • Report any problems or complications experienced by patients following placement of the BioZorb Marker devices to Hologic

    Contact Information

    Customers in the U.S. with questions about this recall should contact Hologic, Inc. at breasthealth.support@hologic.com.

    Additional Resources:

    How do I report a problem?

    Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

    MIL OSI USA News –

  • MIL-OSI USA: ICYMI: Governor Katie Hobbs Follows Through on Promise to Secure Arizona’s Water Future

    Source: US State of Arizona

    Hobbs Takes Action to Shut Down Bad Actor Developers, Protect Groundwater

    Phoenix, AZ – In case you missed it, Governor Katie Hobbs took major action this week to secure Arizona’s water future. On Monday, the Arizona Department of Real Estate issued cease-and-desist orders to a developer attempting to skirt water supply laws to make a profit off illegally pumping Arizona groundwater. Then on Wednesday, ADWR took the first steps towards the creation of a Willcox basin AMA. 

    Here’s what they’re saying:

    Ed Curry, Willcox basin farmer: “This announcement of a potential AMA is a new beginning for the Willcox Basin, and we must continue to work together to move forward to protect our groundwater supplies. I am thankful for the courage of Governor Hobbs and her administration to tackle these issues head on.”

    Mike Laws, Mayor of Willcox: “Our community is facing difficult decisions as Arizona moves forward with an Active Management Area for the Willcox Basin. While there are a range of views on the AMA, the urgency of addressing our water challenges cannot be overstated. Governor Hobbs has demonstrated a strong commitment to protecting Arizona’s water resources, and with no legislative solutions in place, the Governor and Arizona Department of Water Resources have acted with the tools available to them.”

    Steve Kisiel, Willcox Basin homeowner: “Today’s announcement by ADWR to initiate the AMA designation process gives me hope that we will finally have a secure water future here in the Willcox Basin.”

    Mark Jove, WIllcox Basin winegrower: “We support and welcome this step taken towards protecting our water supplies. As a small business vineyard in the Willcox groundwater basin we’ve experienced firsthand the alarming declines in our local water levels due to decades of unchecked, unlimited groundwater pumping. An AMA designation would finally put us on a path to stabilizing this precious and shared resource to safeguard local growers and business owners.”

    Cochise Groundwater Stewards: “For years, we’ve pleaded for groundwater management that protects our property, our families, and our economy. Legislators from both parties have introduced workable bills throughout the last five years – none received a hearing. With the Legislature apparently abandoning us in rural Arizona, it’s time for ADWR to designate a new AMA here. Finally, we are being heard.” 

    MORE BELOW:

    Arizona Republic: AZ regulators issue cease-and-desist for developer they say is building ‘wildcat’ subdivisions

    • State officials allege two limited liability corporations owned by Andrei Polukhtin, 2PHDS and Morning Vista Homes, are building so-called “wildcat” subdivisions via unregulated lot splits in Rio Verde Foothills. That neighborhood made national news last year when it lost its primary water supply.

    • Some areas of the state heavily reliant on groundwater, including most of Maricopa County, are designated as active management areas. There, property owners generally must show real estate regulators proof of legal rights to a 100-year supply of water before selling parcels for larger developments.

    • The action signals growing interest in upholding water and development requirements by state regulators. Democratic Gov. Katie Hobbs directed the Arizona Department of Real Estate last year to take increased action to prevent wildcat developments from popping up around the state.

    KJZZ: Hobbs administration to Rio Verde Foothills developer: Cease and desist amid water concerns

    • Arizona Gov. Katie Hobbs’ administration says it has sent a cease and desist letter to a developer trying to get around water regulations in the unincorporated community of Rio Verde Foothills.

    • Hundreds of homes in Rio Verde Foothills were cut off from their water supply in 2023 due to drought restrictions in neighboring Scottsdale. The state Legislature had to step in to negotiate a temporary fix for the community.

    • Hobbs said she still wants the legislature to take action to close the wildcat subdivision loophole.

    Arizona Daily Star: Arizona takes major step toward regulating groundwater pumping in Willcox area

    • The Arizona Department of Water Resources said Wednesday it’s taking the first steps to usher in groundwater pumping regulation in the Willcox Basin, whose aquifer has dramatically declined due to unregulated pumping by farmers.

    • A group calling itself Cochise Water Stewards said Wednesday that “enough is enough” after a decade-long wait for solutions to Willcox’s collapsing aquifer.

    • Vance Williams, a resident of the Sunizona area southeast of Willcox, said, “I am grateful that ADWR has finally decided to take the first step toward establishing an AMA to protect the groundwater in the Willcox basin. I just wish it had happened sooner as my well in Sunizona went dry in 2020 and I have heard from many other neighbors across the basin whose wells have gone dry.”

    • “The AMA will stop any new large agricultural operations from moving into our area while also putting a halt to expansion of existing irrigation,” Williams said. “I am hopeful that the AMA will also reduce current pumping levels, a necessary step needed to save our aquifer. Thank you to Governor Hobbs and her staff for working to protect the groundwater in the Willcox Basin.”

    Arizona Agenda: Hobbs makes her move

    • Yesterday morning, group chats and inboxes were buzzing in Southeast Arizona: Gov. Katie Hobbs and the Arizona Department of Water Resources have begun the process of designating the Willcox Basin as an “Active Management Area,” which will limit groundwater pumping in the area.

    • And it would be a historical milestone as the first state-initiated “subsequent AMA” in Arizona, highlighting Hobbs’ role as the first governor to push the ADWR to take rural groundwater management seriously.

    • Besides being a strong political move by Hobbs, an AMA designation will “stop the bleeding” in the Willcox Basin while the Legislature continues its policy battles.

    • And now that Hobbs has proven willing to put AMAs in place, legislative stalemate tactics will no longer be an option for her policy opponents. They’ll have to come up with statutory amendments or AMA alternatives that actually pass through the Legislature and survive Hobbs’ veto pen.

     

    MIL OSI USA News –

  • MIL-OSI USA: Attorney General Bonta Secures Felony Conviction of Sirron Croskey for Armed Robbery, Reckless Evading, and Possession of a Loaded Firearm in Public

    Source: US State of California

    Friday, October 25, 2024

    Contact: (916) 210-6000, agpressoffice@doj.ca.gov

    OAKLAND – California Attorney General Rob Bonta today announced the felony conviction of Sirron Croskey for armed robbery, reckless evading, and possession of a loaded firearm in public. Croskey carried out multiple robberies across Contra Costa, Alameda, Santa Clara, and Napa counties, targeting victims in casino parking lots while brandishing a loaded, unregistered firearm to facilitate the crimes. After committing his final robbery in Napa County, Croskey attempted to evade law enforcement by engaging in a high-speed chase with deputies from the Contra Costa Sheriff’s Office. He ultimately left behind the vehicle and the firearm that had been utilized in all the robberies and fled on foot. 

    “Californians deserve to live their lives free from the shadow of violence,” said Attorney General Bonta. “I am immensely proud of my team for their unwavering commitment to justice and for ensuring that those who violate the law are held responsible. When we work together, we get results that create a safer and more secure California for everyone.”

    Croskey pled guilty to one felony count of Reckless Evading, one felony count of Carrying a Loaded Unregistered Firearm in Public, two felony counts of Second-Degree Robbery, and admitted two enhancements for Personal Use of a Firearm. He was sentenced on October 23, 2024 in Contra Costa Superior Court to 9 years, 8 months in State Prison and was ordered to pay restitution in the amount of $9,855 to seven different victims.

    The investigation was conducted by the Contra Costa Sheriff’s Office, the American Canyon Police Department, the Livermore Police Department, the San Jose Police Department and the Department of Justice’s Bureau of Gambling Control. The DOJ’s Special Prosecution Section handled the prosecution of this case. 

    DOJ’s Special Prosecution Section investigates and prosecutes complex criminal cases occurring in California, including fraud, public corruption, “underground economy” crimes, human and labor trafficking, fentanyl trafficking, and organized retail theft. 

    A copy of the criminal complaint can be found here.

    # # #

    MIL OSI USA News –

  • MIL-OSI Security: Greenfield — Update: Missing man located deceased

    Source: Royal Canadian Mounted Police

    October 25, 2024, Greenfield, Nova Scotia… The 78-year-old man who was reported missing from Port Hawkesbury on October 3, 2023, has been located deceased.

    His remains were found by a hunter in a wooded area in Greenfield, close to where his abandoned vehicle was parked.

    The death is not believed to be suspicious in nature; however, the investigation is ongoing.

    Our thoughts are with the man’s loved ones at this difficult time.

    File #: 2023-1472245

    -30-

    Contact:

    Sgt. Deepak PRASAD

    Public Information Officer
    Nova Scotia RCMP
    rcmpns-grcne@rcmp-grc.gc.ca

    MIL Security OSI –

  • MIL-OSI Security: Colorado man convicted of attempting to entice a minor to engage in illegal sexual activity

    Source: Office of United States Attorneys

    Gabriel Estrada, 30, of Denver, Colorado, was convicted by a federal jury for attempting to entice a minor to engage in illegal sexual activity. The four-day trial was held before U.S. District Court Judge Alan B. Johnson.

    According to trial evidence, Estrada used a chat app to meet up with a 13-year-old persona for sexual intercourse. An undercover agent posed as a 13-year-old female, living in Laramie, Wyoming. Estrada messaged the 13-year-old persona asking if she would have sex with him. He went on to ask the 13-year-old persona if she had any friends that would like to join them in the sexual encounter and asked about her sexual experience. Estrada then drove the two hours from his home to Laramie after confirming the minor would engage in other sexual acts with him. Estrada arrived at the location, along with other physical evidence indicative of his intent to engage in sexual acts with the minor and an iPhone. The iPhone contained the text messages to the 13-year-old persona. Estrada testified that he made the decision to drive from his apartment in Denver to Laramie, even after the minor told him her age. Estrada said he did not believe she was actually 13.

    Sentencing has been set for Jan. 13, 2025. Estrada faces 10 years to life imprisonment, up to a $250,000 fine, five years to life supervised release and a $100 special assessment. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors in both cases.

    This crime was investigated by the Laramie Police Department and Federal Bureau of Investigation and the case was prosecuted by Assistant U.S. Attorney Z. Seth Griswold.

    Case No. CR-24-00033

    MIL Security OSI –

  • MIL-OSI USA: ICYMI: Ernst Exposes Kamala Harris’ Empty Promises to Small Businesses

    US Senate News:

    Source: United States Senator Joni Ernst (R-IA)
    WASHINGTON – In case you missed it, National Review broke down a new report commissioned by U.S. Senator Joni Ernst (R-Iowa), the top Republican on the Senate Small Business and Entrepreneurship Committee, exposing Kamala Harris’ empty promises and radical agenda that has hurt American small businesses.
    In the report, Senator Ernst conducts a deep dive of the troubling trend of small businesses getting squeezed out of the federal marketplace, despite Kamala Harris’ claims otherwise.
    In August, Senator Ernst hosted an entrepreneur expo to bring hundreds of Iowa small business owners together to hear from speakers, join breakout sessions with federal agencies, and get small businesses back in the federal contracting game.
    Kamala Harris Hasn’t Delivered on Her Promises to Small Businesses, GOP Senate Report Claims
    By: Haley Strack
    Kamala Harris’s campaign promises to small businesses are more fiction than reality, according to a new report by the Senate Small Business and Entrepreneurship Committee.
    Commissioned by ranking member Senator Joni Ernst (R., Iowa), the report compares Harris’s campaign aspirations for small businesses with the work she’s done in the past three and a half years as vice president.
    Although Harris’s website says that she will “increase the share of federal contract dollars going to small businesses,” since Harris has been vice president, the number of small businesses contracting with the federal government has steadily decreased. In 2020, the number was 94,044; in 2021, it was 88,790; in 2022, it was 85,014; and in 2023, it was at its lowest, 84,053. The federal government has seen about a 50 percent decrease in its small-business vendors since 2008.
    “Despite declining engagement, the reported government dollars allocated to remaining small businesses is increasing,” the report says. “Since FY 2015, the U.S. Small Business Administration (SBA) has reported yearly increases in government-wide small business spending. These awards totaled $90.7 billion in FY 2015, $100 billion in FY 2016, $105.7 billion in FY 2017, $120.8 billion in FY 2018, $132.9 billion in FY 2019, $145.7 billion in FY 2020, $154.2 billion in FY 2021, $162.9 billion in FY 2022, and $178.6 billion to small businesses in FY 2023. This trend seems to indicate a willingness within the USG to award contracts to small businesses. In reality, it signals an unhealthy consolidation within the federal supplier base and an entrenchment of established contractors capturing a growing market share of overall small business dollars, to the detriment of new and emerging firms seeking to capture the same market share.’
    Harris plans to increase the deduction on start-up expenses, and has promised to secure 25 million new small business applications if she becomes president. But Harris’s expanse of government programs for small businesses isn’t enough to offset the harm inflation has imposed upon those businesses, the report suggests.
    “Kamala Harris claims to be a friend to mom-and-pop shops, but she has delivered nothing but price hikes and miles of red tape,” Ernst said. “She loves to talk about creating an opportunity economy, but the only opportunities are for those aligned with the Green New Deal agenda, including Chinese manufacturers. Unlike Kamala Harris, I have worked to enact real solutions to make life easier for job creators and expand opportunities for the heartland to contract with the federal government and reverse the troubling trend of small businesses getting squeezed out of the marketplace.”
    The Biden-Harris Small Business Administration announced in September that it would accept applications for Small Business Lending Company (SBLC) licenses and Community Advantage (CA) SBLC licenses, programs the administration said would prioritize “reducing climate change.”
    “The levers of government should never be used to pick winners and losers based on political priorities. Instead of wasting tax dollars on another Green New Deal program, the SBA needs to prioritize lowering costs for the millions of small businesses struggling from the Biden-Harris 20 percent inflation price hike,” Ernst said in a statement.
    Meanwhile, Ernst has proposed the Accountability and Clarity in Contracts to Engage Small Business Suppliers, which she says will make federal contracting opportunities accessible for small businesses, and “ensure the participation of a broad spectrum of small businesses across all industries.”

    MIL OSI USA News –

  • MIL-OSI USA: Capito Announces Grant Funding for Two West Virginia Railway Projects

    US Senate News:

    Source: United States Senator for West Virginia Shelley Moore Capito
    CHARLESTON, W.Va. — Today, U.S. Senator Shelley Moore Capito (R-W.Va.), a leader on both the Senate Appropriations and Commerce Committees, announced a two grant awards from the U.S. Department of Transportation’s (DOT) Consolidated Rail Infrastructure and Safety Improvements (CRISI) program for West Virginia railway updates.
    These grants, which were made possible through provisions included in the bipartisan Infrastructure Investment and Jobs Act (IIJA) that Senator Capito helped negotiate and craft, will provide funding for the reconstruction and rehabilitation of railroads, as well as bridge repairs and renovations.
    “Maintaining and ensuring safe railways is an important part of our state’s infrastructure, which is why I worked to increase this critical infrastructure grant program in the Infrastructure Investment and Jobs Act,” Senator Capito said. “These grants will provide critical funding to projects that aim to modernize our railways and bridges, ensuring we are prepared for the future. West Virginia continues to see the benefits of the Infrastructure Investment and Jobs Act with more economic growth and opportunities, and these grants are just another example.”
    Individual award details listed below:
    $22,796,000 IIJA CRISI grant funding to Winchester & Western Railroad Acquisition, LLC (Martinsburg, W.Va.) for final design and construction activities to rehabilitate segments of the Winchester & Western Railroad mainline in West Virginia and Maryland to eliminate all remaining legacy rail and old tie structure. The project will enhance safety, efficiency, and resiliency as the project will return the line to a state of good repair.
    $6,912,000 IIJA CRISI grant funding to Cathcart Rail, LLC for a project that will complete final design and construction activities to repair two bridges on the Belpre Industrial Parkersburg Railroad (BIP) in West Virginia and Ohio. Specifically, the project addresses structural deficiencies in the historic B&O Sixth Street Railroad Bridge that spans Parkersburg, W.Va. and Belpre, Ohio, including cross tie replacement, stringer/floor beam repair, bracing and timber replacement, and replacing stones under bearings.

    MIL OSI USA News –

  • MIL-OSI Video: National Guard honors National Day of the Deployed

    Source: US National Guard (video statements)

    Each year, on Oct. 26, the United States observes the National Day of the Deployed, which is dedicated to honoring all service members who have been deployed in service to our country and acknowledging the sacrifices their families make during these times. This year, as always, to honor and express our deepest gratitude to all the brave men and women of the National Guard who have answered the call of duty, as well as the families who support them. (Video by Master Sgt. Brandy Fowler)

    https://www.youtube.com/watch?v=ZF8FYT-bdDc

    MIL OSI Video –

  • MIL-OSI USA: Van Orden Sounds Alarm on Half of Wisconsin Federal Prison Inmate Population Being Illegal Aliens

    Source: United States House of Representatives – Congressman Derrick Van Orden (Wisconsin 3rd)

    WASHINGTON, D.C. – This week, Congressman Derrick Van Orden (WI-03) participated in a House Judiciary Committee field hearing in Milwaukee on the effects of the current southwest border crisis on Wisconsin residents and communities. 

    During the hearing, Congressman Van Orden questioned the witness panel on the Federal Correctional Institution Oxford holding 650 illegal aliens who committed felonies in the facility, which is over half of the facility’s housing capacity of 1,200. In a meeting with Oxford’s administrators a week prior to the hearing, Rep. Van Orden was informed that the cost to house a single inmate at Oxford is $42,000 per year, leading the facility to spend over $27 million per year on housing the illegal aliens alone in their custody. Federal law requires that illegal aliens who are convicted of felonies while residing in the U.S. must complete their sentence in the U.S. prison system before being deported.

    To watch Rep. Van Orden’s line of questioning during the hearing, click here or below.

    (watch)

    Rep. Van Orden addressing the Oxford Federal Prison illegal alien population with Republican Wisconsin Senator Ron Johnson: 

    Rep. Van Orden:

    “The criminal illegal alien that Congressman Tiffany referred to earlier made his way across the border with Venezuelan gang tattoos. Those are not a, “Live to Ride, Ride to Live” tattoo. That’s either: You’re a member of that gang and you have that tattoo, or they will cut it off you while you’re living, so that should have been taken for what it is at the border. This person never should have been allowed in the country, made his way to Minneapolis, arrested for crimes after the Dane County Sheriff had warrants out for strangulation and some other violent crimes, and didn’t bother following up with it because both those places are Sanctuary Cities. 

    “Then he came to a place a half mile away from where four of my grandchildren live and brutally raped a mother and assaulted a daughter over a period of days. This could have been stopped at any point, and solely because the Biden Administration is pushing an incredibly horrible political agenda, this is going to keep happening over and over and over again.

    “Senator Johnson, I found this out last week, and I want to know if you’re tracking. We went to the federal prison in Oxford in my district, and half of the prisoners are illegal aliens. Are you tracking the volume of what’s taking place? This is the second and third order effect of opening up these borders, but when half of an institution is occupied by illegal aliens, that’s something that I’m hoping we’re going to be looking at here under a Trump presidency. Are you tracking this, Sir?”

    Sen. Johnson:

    “I’m not, but it’s not surprising. It’s not just going to be federal prisons; it’s going to be local prisons and they’re going to be bearing the brunt of the cost of this. I think the House Committee said that the cost of dealing with this crisis is about $150 billion per year across all governmental units. That’s a massive cost imposed on us by the Biden-Harris administration, and that gang member never should have been let into this country. The vast majority of people are as sympathetic as I am with people who want to come here for opportunity but don’t qualify for asylum. There is a very tough standard. You have to be persecuted by your government or threatened with persecution. This open border is a setback in establishing a functioning legal immigration that is controlled and brings people in to improve our economy. I’m for a robust legal immigration system, and we need one. We certainly need one here in Wisconsin – certainly in your district with all the farmers. We need workers, we need laborers, and immigrant laborers do a great job. They come here, they work their tail off, but it has to be a legal system. You cannot establish that until you secure the border. So, Biden has set back establishing that legal system…” 

    Rep. Van Orden:

    “At one point, they had 17 to 20 some thousand rotating through Afghan refugees at Fort McCoy, which I represent. We went back and looked at every single Afghan that came here that was eligible for the Special Immigrant Visa, meaning they worked with the United States government during the war. Guess how many of those were qualified for SIV – zero…

    “The last thing we’re looking at is about 250,000 missing children the Biden administration has lost. The Biden administration, under the Harris Border Czar, is solely responsible for losing almost a quarter of a million children in the United States that are most likely being trafficked, knowing full well that they were releasing them into the hands of members of transnational criminal organizations and human sex traffickers.”

    MIL OSI USA News –

  • MIL-OSI USA: Welch, Blumenthal Call on Dept. of Justice to Investigate Elon Musk’s Cash Sweepstakes to Swing-State Voters

    US Senate News:

    Source: United States Senator Peter Welch (D-Vermont)

    WASHINGTON, D.C. – U.S. Senator Peter Welch (D-Vt.), and U.S. Senator Richard Blumenthal (D-Conn.), members of the Senate Judiciary Committee, today wrote to U.S. Attorney General Merrick Garland asking the Department of Justice to investigate whether Elon Musk, through his political action committee America PAC, has violated federal campaign finance law by providing cash rewards to individuals in seven swing states if they sign a petition that requires them to be registered to vote.  
    Section 10307(c) of Title 52 of the U.S. Code states it is illegal if an individual “pays or offers to pay or accepts payment either for registration to vote or for voting.” Earlier this week, CNN reported the Department had warned Musk and his super PAC that his actions may be in violation of the law. 
    “Musk’s reward scheme appears to violate federal campaign finance law. It is explicitly designed to induce people to register to vote. Moreover, the Department of Justice’s own Election Crimes Manual states that a violation of federal campaign finance laws can occur when ‘cash’ or ‘lottery chances’ are ‘intended to induce or reward the voter for engaging in one or more acts necessary to cast a ballot,’” the lawmakers write.  
    “There is no place for vote buying in our democracy. As the Department has recognized, voting should never ‘degenerate into a spending contest, with the victor being the candidate who can pay the most voters’…” the lawmakers conclude.“…Permitting this scheme to proceed without consequences makes a mockery of democracy and the law. We urge you to investigate whether Elon Musk’s cash prizes are prohibited payments for voter registration and take appropriate enforcement action, including prosecution, if his actions prove to be illegal.” 
    Read the letter below and download it here: 
    Dear Attorney General Garland,
    As you know, Elon Musk has been providing cash rewards to voters in seven states if they sign a petition related to his political action committee—America PAC. Individuals must be a registered voter, or register to vote, to qualify for his financial giveaways, which include payments of $47, $100, and a $1 million daily lottery. Campaign finance law states it is illegal if anyone “pays or offers to pay…either for registration to vote or for voting.” 
    Musk’s reward scheme appears to violate federal campaign finance law. It is explicitly designed to induce people to register to vote. Moreover, the Department of Justice’s own Election Crimes Manual states that a violation of federal campaign finance laws can occur when “cash” or “lottery chances” are “intended to induce or reward the voter for engaging in one or more acts necessary to cast a ballot.” 
    There is no place for vote buying in our democracy. As the Department has recognized, voting should never “degenerate into a spending contest, with the victor being the candidate who can pay the most voters.” According to public reports, the Department warned America PAC this week that the petition lottery may be in violation of federal law. If so, permitting this scheme to proceed without consequences makes a mockery of democracy and the law. We urge you to investigate whether Elon Musk’s cash prizes are prohibited payments for voter registration and take appropriate enforcement action, including prosecution, if his actions prove to be illegal. 
    Sincerely, 
    Senator Peter Welch 
    Senator Richard Blumenthal 

    MIL OSI USA News –

  • MIL-OSI USA: SEC Adopts Rule Amendments and New Rule to Improve Risk Management and Resilience of Covered Clearing Agencies

    Source: Securities and Exchange Commission

    The Securities and Exchange Commission today adopted rule amendments and a new rule to improve the resilience and recovery and wind-down planning of covered clearing agencies. The rule amendments establish new requirements regarding a covered clearing agency’s collection of intraday margin as well as a covered clearing agency’s reliance on substantive inputs to its risk-based margin model. The new rule prescribes requirements for the contents of a covered clearing agency’s recovery and wind-down plan.

    “Recovery and wind-down planning enhances the resiliency and continuity of our market plumbing,” said SEC Chair Gary Gensler. “I’m pleased that today’s amendments will benefit investors, issuers, and the markets alike.”

    Specifically, regarding intraday margin collection, the rule amendments require that a covered clearing agency that provides central counterparty services has policies and procedures to establish a risk-based margin system that monitors intraday exposures on an ongoing basis, includes the authority and operational capacity to make intraday margin calls as frequently as circumstances warrant (including when risk thresholds specified by the covered clearing agency are breached or when the products cleared or markets served display elevated volatility), and documents when the covered clearing agency determines not to make an intraday call pursuant to its written policies and procedures.

    The rule amendments regarding substantive inputs require that a covered clearing agency that provides central counterparty services has policies and procedures to establish a risk-based margin system that uses reliable sources of substantive inputs, uses procedures to address circumstances in which substantive inputs are not readily available or reliable (to ensure that the covered clearing agency can continue to meet its credit exposures to its participants), and that such procedures must include either the use of price data or substantive inputs from an alternate source or a risk-based margin system that does not rely on substantive inputs that are unavailable or unreliable.  

    Existing rules require a covered clearing agency to have a recovery and wind-down plan, and the new rule requires such an entity to specify nine elements for its plan. The new rule’s required elements address: planning (e.g., the identification and use of scenarios, triggers, tools, staffing, and service providers); timing and implementation of the plans; and testing and board approval of the plans.

    The Commission is adopting two compliance dates: (1) 150 days after publication in the Federal Register for a covered clearing agency to file any required proposed rule changes or advance notices with the Commission; and (2) 390 days after publication in the Federal Register for such proposed rule changes and advance notices to be effective.

    MIL OSI USA News –

  • MIL-OSI USA: H.R. 8666, a bill to amend title 28, United States Code, to authorize holding court for the Central Division of Utah in Moab and Monticello

    Source: US Congressional Budget Office

    H.R. 8666 would authorize federal district courts in the Central Division of Utah to hold proceedings in the cities of Moab and Monticello. Under current law, those proceedings are held in the cities of Salt Lake, Provo, and St. George. 

    Using information from the Administrative Office of the U.S. Courts about current operating costs for the courts, CBO estimates that implementing the bill would cost less than $500,000 over the 2025-2029 period. Any related spending would be subject to the availability of appropriated funds.

    MIL OSI USA News –

  • MIL-OSI USA: H.R. 7177, a bill to amend title 28, United States Code, to consolidate certain divisions in the Northern District of Alabama

    Source: US Congressional Budget Office

    H.R. 7177 would codify the on-going consolidation of operations of federal district courts in the Northern District of Alabama by reducing the number of divisions within that district from seven to five. As a result of the changes, CBO expects that court proceedings would no longer be held in the cities of Decatur, Gadsden, and Jasper, and would instead be held in other cities within the district. 

    According to the Administrative Office of the U.S. Courts, court operations in Gadsden and Jasper have been transferred to other cities, and operations in Decatur will transfer in 2025. On that basis, CBO estimates that enacting the bill would have no budgetary effects. 

    MIL OSI USA News –

  • MIL-OSI USA: H.R. 9720, AI Incident Reporting and Security Enhancement Act

    Source: US Congressional Budget Office

    H.R. 9720 would require the National Institute of Standards and Technology (NIST) to establish common definitions and identify characteristics of security vulnerabilities of artificial intelligence (AI) that would make the National Vulnerability Database inappropriate for managing those vulnerabilities. The bill also would require NIST to support the development of standards and guidance for technical vulnerability management processes related to AI and to update the database and associated vulnerability management processes. Finally, H.R. 9720 would require NIST to work with interested parties to develop and then report to the Congress on a process to voluntarily collect, report, and track substantial AI security incidents.

    Based on the cost of similar requirements, CBO expects that NIST will need three employees, at an average annual cost of $250,000 per person in 2025, to carry out the requirements of H.R. 9720. Accounting for anticipated inflation, CBO estimates that implementing the bill would cost $3 million over the 2025-2029 period. Any related spending would be subject to the availability of appropriated funds.

    MIL OSI USA News –

  • MIL-OSI USA: H.R. 8689, Amtrak Executive Bonus Disclosure Act

    Source: US Congressional Budget Office

    H.R. 8689 would require Amtrak to include information on the base pay and bonus compensation of its executive officers in its annual report to the Congress and post the report on its website. Because Amtrak is considered a nonfederal entity, CBO estimates that enacting the bill would have no effect on the federal budget. 

    The legislation would impose a private-sector mandate as defined in the Unfunded Mandates Reform Act (UMRA) on Amtrak by marginally expanding an existing reporting requirement. CBO estimates that the cost to Amtrak would fall well below the threshold established in UMRA for private-sector mandates ($200 million in 2024, adjusted annually for inflation). 

    H.R. 8689 would not impose intergovernmental mandates as defined in UMRA.

    MIL OSI USA News –

  • MIL-OSI USA: Franklin County Mobile Disaster Recovery Center Reopens in New Location

    Source: US Federal Emergency Management Agency

    Headline: Franklin County Mobile Disaster Recovery Center Reopens in New Location

    Franklin County Mobile Disaster Recovery Center Reopens in New Location

    TALLAHASSEE, Fla.– The Mobile Disaster Recovery Center in Franklin County is open at the Eastpoint County Building Department to provide one-on-one help to Floridians affected by Hurricane Helene. Survivors of Hurricane Milton or Hurricane Debby can also be served by the center.Franklin CountyEastpoint County Building Department248 US Hwy. 98Eastpoint, FL 32328Hours: 8 a.m.–4:30 p.m. Friday-Sunday through Oct. 27, 2024.When this center moves to a new location, details will be provided to the public.Survivors do not need to visit a center to apply for assistance. Homeowners and renters are encouraged to apply online at DisasterAssistance.gov or by using the FEMA App. You may also apply by phone at 800-621-3362. If you choose to apply by phone, please understand wait times may be longer because of increased volume for multiple recent disasters. Lines are open every day and help is available in most languages. If you use a relay service, captioned telephone or other service, give FEMA your number for that service. For an accessible video on how to apply for assistance go to FEMA Accessible: Applying for Individual Assistance – YouTube.For the latest information about Hurricane Milton recovery, visit fema.gov/disaster/4834. For Hurricane Helene, visit fema.gov/disaster/4828. For Hurricane Debby, visit fema.gov/disaster/4806. Follow FEMA on X at x.com/femaregion4 or on Facebook at facebook.com/fema.
    kirsten.chambers
    Fri, 10/25/2024 – 20:25

    MIL OSI USA News –

  • MIL-OSI Security: U.S. Attorney’s Office Announces Sentencing of Mescalero Man for Stabbing Assault

    Source: Office of United States Attorneys

    ALBUQUERQUE – A Mescalero man was sentenced to 46 months in federal prison for the repeated stabbing of a woman on the Mescalero Apache reservation.

    There is no parole in the federal system.

    According to court documents, on May 18, 2023, Lestat Cree Valdez, 21, an enrolled member of the Mescalero Apache tribe, straddled Jane Doe and stabbed her repeatedly in the head, face, and chest with a knife, with the intent to cause bodily harm. As a result of the assault, Jane Doe suffered serious bodily injury.

    Upon his release from prison, Valdez will be subject to three years of supervised release.

    U.S. Attorney Alexander M.M. Uballez, and Raul Bujanda, Special Agent in Charge of the Federal Bureau of Investigation’s Albuquerque Field Office, made the announcement today.

    This case was investigated by the Las Cruces Resident Agency of the Federal Bureau Investigation with assistance from the Bureau of Indian Affairs. Assistant United States Attorney Joni Autrey Stahl is prosecuting the case.

    # # #

    MIL Security OSI –

  • MIL-OSI Security: Twelve Defendants Charged in Alleged Methamphetamine Conspiracy

    Source: Office of United States Attorneys

    Source: Office of United States Attorneys

    MACON, Ga. – A newly unsealed federal indictment charges a dozen defendants with allegedly participating in a methamphetamine production and trafficking conspiracy operating out of a ten-acre Walton County property.

    According to the indictment unsealed on Oct. 23, and the search warrant, as well as statements made public in court, on Aug. 13, 2024, a federal search warrant was executed at 2370 Mountain Creek Church Road, Monroe, Georgia, as part of a joint law enforcement operation, where agents seized a total of 4,346 grams of “finished” crystal methamphetamine, 22 gallons of liquid methamphetamine (approximately equivalent to 377 kilograms of finished crystal methamphetamine) and $5,401. A federal search warrant was also executed on a Chevrolet Traverse occupied by Yuretzi Gomez, Yirla Gomez, Rafael Gomez and Uriel Garcia where agents recovered 1,046 grams of methamphetamine and $4,350 in cash. In addition, agents seized 4,523 grams of methamphetamine inside a Camaro occupied by Jared Calhoun and Ebony Jones-Tate.

    The following defendant charged by indictment will have his initial appearance before U.S. Magistrate Judge Charles H. Weigle on Nov. 4:

    James Len Ramey, 52, of Comer, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine.

    The following defendants charged by indictment have had their initial appearances before U.S. Magistrate Judge Weigle:

    Christopher Hyatt, 44, of LaGrange, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Kendell Cawthon, 59, of Baldwin, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Bonterris Turner, 44, of Athens, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Demetrius Appling, 36, of Crawford, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Andrea Robinson, 44, of Cleveland, Georgia; is charged with one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum of 20 years in prison and a $250,000 fine;

    Yuretzi Adame Gomez, 39, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Yirla Adame Gomez, 24, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Rafael Gomez Flores, 21, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Uriel Garcia, 32, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Jared Calhoun, 32, of Birmingham, Alabama, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine; and

    Ebony Jones-Tate, 32, of Birmingham, Alabama, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine.

    The case is being investigated by the FBI’s Middle Georgia Safe Streets Gang Task Force, the Drug Enforcement Administration (DEA), the Georgia Bureau of Investigation (GBI), the Walton County Sheriff’s Office, the Athens-Clarke County Police Department and the Georgia State Patrol (GSP).

    Assistant U.S. Attorney Mike Morrison is prosecuting the case for the Government.

    An indictment is only an allegation of criminal conduct, and all defendants are presumed innocent until and unless proven guilty in a court of law beyond a reasonable doubt.

    MACON, Ga. – A newly unsealed federal indictment charges a dozen defendants with allegedly participating in a methamphetamine production and trafficking conspiracy operating out of a ten-acre Walton County property.

    According to the indictment unsealed on Oct. 23, and the search warrant, as well as statements made public in court, on Aug. 13, 2024, a federal search warrant was executed at 2370 Mountain Creek Church Road, Monroe, Georgia, as part of a joint law enforcement operation, where agents seized a total of 4,346 grams of “finished” crystal methamphetamine, 22 gallons of liquid methamphetamine (approximately equivalent to 377 kilograms of finished crystal methamphetamine) and $5,401. A federal search warrant was also executed on a Chevrolet Traverse occupied by Yuretzi Gomez, Yirla Gomez, Rafael Gomez and Uriel Garcia where agents recovered 1,046 grams of methamphetamine and $4,350 in cash. In addition, agents seized 4,523 grams of methamphetamine inside a Camaro occupied by Jared Calhoun and Ebony Jones-Tate.

    The following defendant charged by indictment will have his initial appearance before U.S. Magistrate Judge Charles H. Weigle on Nov. 4:

    James Len Ramey, 52, of Comer, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine.

    The following defendants charged by indictment have had their initial appearances before U.S. Magistrate Judge Weigle:

    Christopher Hyatt, 44, of LaGrange, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Kendell Cawthon, 59, of Baldwin, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Bonterris Turner, 44, of Athens, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Demetrius Appling, 36, of Crawford, Georgia, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Andrea Robinson, 44, of Cleveland, Georgia; is charged with one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum of 20 years in prison and a $250,000 fine;

    Yuretzi Adame Gomez, 39, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Yirla Adame Gomez, 24, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Rafael Gomez Flores, 21, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Uriel Garcia, 32, of Mexico, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine;

    Jared Calhoun, 32, of Birmingham, Alabama, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine; and

    Ebony Jones-Tate, 32, of Birmingham, Alabama, is charged with one count of conspiracy to possess with intent to distribute methamphetamine and one count of possession with intent to distribute methamphetamine. If convicted, the defendant faces a maximum sentence of life imprisonment with a mandatory minimum sentence of ten years in prison and a $10 million fine.

    The case is being investigated by the FBI’s Middle Georgia Safe Streets Gang Task Force, the Drug Enforcement Administration (DEA), the Georgia Bureau of Investigation (GBI), the Walton County Sheriff’s Office, the Athens-Clarke County Police Department and the Georgia State Patrol (GSP).

    Assistant U.S. Attorney Mike Morrison is prosecuting the case for the Government.

    An indictment is only an allegation of criminal conduct, and all defendants are presumed innocent until and unless proven guilty in a court of law beyond a reasonable doubt.

    MIL Security OSI –

  • MIL-OSI Security: New Jersey Man Charged For Multi-Year, Multi-Million Dollar Fraud

    Source: Office of United States Attorneys

    Damian Williams, the United States Attorney for the Southern District of New York; James E. Dennehy, the Assistant Director in Charge of the New York Field Office of the Federal Bureau of Investigation (“FBI”); Thomas Fattorusso, the Special Agent in Charge of the New York Field Office of the Internal Revenue Service, Criminal Investigation (“IRS-CI”); and Francis J. Russo, the Director of the New York Field Office of U.S. Customs and Border Protection (“CBP”),  announced today the arrest of ARSEN LUSHER, who orchestrated a scheme to defraud more than 20 investors of more than $5 million between 2017 and 2021.  LUSHER was arrested earlier today and will be presented this afternoon before U.S. Magistrate Judge Gary Stein.

    U.S. Attorney Damian Williams said: “For years, the defendant allegedly solicited investors’ funds by representing that he had a hugely profitable trucking business.  That wasn’t true, and the defendant instead allegedly used the funds to run a classic Ponzi scheme, enriching himself along the way.  When luck ran out, the victims sustained millions of dollars in losses.  Today’s arrest serves as a stark reminder that the illusion of success built on fraud and deceit will inevitably fail.”

    FBI Assistant Director James E. Dennehy said: “For four years, Arsen Lusher allegedly defrauded numerous victims of more than $5 million by cycling their investments to conceal the business’s inability to produce its promised returns, and altered official tax documents to reflect inflated balances in furtherance of this ploy.  The alleged empty assurances allowed the defendant to wrongfully haul in funding from investors and selfishly benefit from their losses.  The FBI will continue to disrupt and hit the brakes on any investment scheme rooted in deceit.”

    IRS-CI Special Agent in Charge Thomas Fattorusso said: “It’s alleged Lusher acted with impunity for years, deceiving over 20 investors out of more than five million dollars.  He created a ‘get-rich-quick’ scheme, then sold his victims a dream of high-returns on their investment.  Instead of a profit, investors were left with a loss of money and of trust.  Today’s arrest ensures that Lusher can now be held accountable for his alleged fraud.”

    CBP Director Francis J. Russo said: “U.S. Customs and Border Protection is proud to have played an important role in this investigation that resulted in the takedown of an elaborate conspiracy to defraud the United States.  This case serves as a great example of how collaborative law enforcement efforts can dismantle nefarious enterprises that cause economic harm to their competitors.”

    According to the allegations in the Complaint unsealed today in Manhattan federal court:[1]

    Between 2017 and 2021, LUSHER engaged in a scheme to defraud more than 20 victims of more than $5 million.  LUSHER and a small group of trusted lieutenants acting at LUSHER’s direction solicited investments from the victims, usually by representing that LUSHER had a profitable trucking business that enjoyed delivery and installation contracts with multiple large retailers.  LUSHER and his lieutenants typically represented that the victims’ investments would fund the purchase of trucks, each truck costing around $45,000.  Through written and signed investment agreements, LUSHER and his lieutenants normally guaranteed the victims that their investments would generate high rates of return over a fixed period—typically between 30 and 40 percent over one or two years.  In that way, LUSHER succeeded in raising more than $40 million.

    In fact, though, LUSHER did not have a large trucking business.  Instead, LUSHER had a small trucking business that performed a small amount of work—less than $300,000—for just one large retailer.  The amount that LUSHER earned from his legitimate trucking business could not have compensated the victims and produced the promised returns.

    Indeed, LUSHER did not use the victims’ funds to purchase trucks or to grow his trucking business.  Instead, for years, LUSHER engaged in a Ponzi scheme: LUSHER paid earlier victims with later victims’ funds.  LUSHER also used the victims’ funds to enrich himself, such as by gambling or shopping for high-end goods.  In that way, LUSHER was able to sustain his scheme for a number of years.  But in early 2021, the scheme collapsed, leaving numerous victims with losses totaling more than $5 million. 

    LUSHER used fake documents to carry out his scheme.  For example, in December 2020, LUSHER caused to be sent to a particular victim an apparent U.S. Income Tax Return for an S Corporation for one of the companies that LUSHER controlled and used to perpetrate his scheme.  That alleged tax return was falsified:  the accountant listed as having prepared the return did not, in fact, prepare it.  And in February 2021, LUSHER altered account balances on an email sent by a bank employee to make it appear that LUSHER’s companies had healthy account balances when, in fact, they did not.  Specifically, while the bank employee wrote that LUSHER’s companies had account balances of $8,767.26 and $320.76, LUSHER altered the bank employee’s email before forwarding it to state that his companies had account balances of $1,228,767.26 and $987,320.76 (italics and bold added).  In other words, LUSHER altered the bank employee’s email such that the account balances for his companies were approximately 140 times and 3,078 times greater than they actually were.  LUSHER then caused that falsified email to be sent to a particular victim.

    If you believe you or your family has been a victim of LUSHER’s fraud, please contact XtremeHDtips@fbi.gov.

    *                *                *

    LUSHER, 49, of Millstone, New Jersey, is charged with one count of wire fraud, which carries a maximum sentence of 20 years in prison, and one count of aggravated identity theft, which carries a mandatory consecutive sentence of two years in prison.

    The statutory maximum penalties in this case are prescribed by Congress and are provided here for informational purposes only, as any sentencing of the defendant will be determined by a judge.

    Mr. Williams praised the outstanding investigative work of the FBI, the IRS, the CBP, and the New York City Police Department. 

    This case is being handled by the Office’s General Crimes Unit.  Assistant U.S. Attorney Joseph H. Rosenberg is in charge of the prosecution.

    The charges contained in the Complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.

    [1] As the introductory phrase signifies, the entirety of the text of the Complaint, and the description of the Complaint set forth in this press release, constitute only allegations, and every fact described should be treated as an allegation.

    MIL Security OSI –

  • MIL-OSI Security: Individual On Parole For Robbery In New Jersey Indicted For Two More Robberies In Florida

    Source: Office of United States Attorneys

    Tampa, Florida – United States Attorney Roger B. Handberg announces the  unsealing of an indictment charging Jose Rodriguez (65, New Jersey) with robbery, attempted robbery, and possession of a firearm by a convicted felon. If convicted on all counts, Rodriguez faces a maximum penalty of life in federal prison. 

    According to court documents, on August 4, 2024, Rodriguez entered a pizza restaurant located in a shopping plaza in Tampa and attempted to rob the restaurant at gunpoint. The clerks fled in fear, and Rodriguez ultimately left empty handed.

    Approximately one month later, on September 11, 2024, Rodriguez returned to the same plaza. This time, he walked into a cellphone store and attempted to rob it at gunpoint. During the robbery, Rodriguez directed an employee to the business’s safe in a back room while stating, “Don’t move or I’ll shoot you.”

    Two days later, ATF special agents and deputies from the Hillsborough County Sheriff’s Office found the vehicle used during the two incidents. Surveillance of that vehicle identified Rodriguez, and a subsequent search warrant of his residence revealed a pistol—which he is prohibited from possessing due to his status as a convicted felon. That pistol had been reported stolen by an elderly man in New Jersey whom Rodriguez had previously cared for. At the time of these incidents, Rodriguez was on parole in New Jersey for robbery.

    An indictment is merely a formal charge that a defendant has committed one or more violations of federal criminal law, and every defendant is presumed innocent unless, and until, proven guilty. 

    This case was investigated by the Bureau of Alcohol, Tobacco, Firearms and Explosives, the Hillsborough County Sheriff’s Office, and the Tampa Police Department. It will be prosecuted by Assistant United States Attorney Diego F. Novaes.

    This case is part of Project Safe Neighborhoods (PSN), a program bringing together all levels of law enforcement and the communities they serve to reduce violent crime and gun violence, and to make our neighborhoods safer for everyone. On May 26, 2021, the Department launched a violent crime reduction strategy strengthening PSN based on these core principles: fostering trust and legitimacy in our communities, supporting community-based organizations that help prevent violence from occurring in the first place, setting focused and strategic enforcement priorities, and measuring the results.

    MIL Security OSI –

  • MIL-OSI China: China expels Philippine vessels for unlawfully entering waters near Tiexian Jiao

    Source: China State Council Information Office

    A China Coast Guard (CCG) spokesperson on Saturday said two Philippine vessels have been expelled for unlawfully intruding into waters near Tiexian Jiao of China’s Nansha Qundao.

    The vessels, which attempted to illegally land on the reef and collect sand samples on Friday, have been warned and driven away by the CCG, according to spokesperson Liu Dejun.

    MIL OSI China News –

  • MIL-OSI USA: McConnell Comments on Hegseth Nomination

    US Senate News:

    Source: United States Senator for Kentucky Mitch McConnell
    Washington, D.C. – U.S. Senator Mitch McConnell (R-KY), Chairman of the Senate Appropriations Subcommittee on Defense, issued the following statement today on the nomination of Pete Hegseth to serve as Secretary of Defense:
    “The most consequential cabinet official in any Administration is the Secretary of Defense. In the face of the gravest threats to U.S. national security interests since World War II, this position is even more important today.
    “Major adversaries are working closer together to undermine U.S. interests around the world. And America’s military capabilities and defense industrial capacity are increasingly insufficient to deter or prevail in major conflict with China or Russia, especially given the real risk of simultaneous challenges from other adversaries like Iran or North Korea.
    “Stewardship of the United States Armed Forces, and of the complex bureaucracy that exists to support them, is a massive and solemn responsibility. At the gravest moments, under the weight of this public trust, even the most capable and well-qualified leaders to set foot in the Pentagon have done so with great humility – from George Marshall harnessing American enterprise and Atlantic allies for the Cold War, to Caspar Weinberger orchestrating the Reagan build-up, to Bob Gates earning the wartime trust of two Commanders-in-Chief, of both parties.
    “Mere desire to be a ‘change agent’ is not enough to fill these shoes. And ‘dust on boots’ fails even to distinguish this nominee from multiple predecessors of the last decade. Nor is it a precondition for success. Secretaries with distinguished combat experience and time in the trenches have failed at the job.
    “Effective management of nearly 3 million military and civilian personnel, an annual budget of nearly $1 trillion, and alliances and partnerships around the world is a daily test with staggering consequences for the security of the American people and our global interests.
    “Mr. Hegseth has failed, as yet, to demonstrate that he will pass this test. But as he assumes office, the consequences of failure are as high as they have ever been.
    “The United States faces coordinated aggression from adversaries bent on shattering the order underpinning American security and prosperity. In public comments and testimony before the Armed Services Committee, Mr. Hegseth did not reckon with this reality.
    “President Trump has rightly called on NATO allies to spend more on our collective defense. But the nominee who would have been responsible for leading that effort wouldn’t even commit to growing America’s defense investment beyond the low bar set by the Biden Administration’s budget requests.
    “In his testimony before the Committee, Mr. Hegseth provided no substantial observations on how to defend Taiwan or the Philippines against a Chinese attack, or even whether he believes the United States should do so. He failed, for that matter, to articulate in any detail a strategic vision for dealing with the gravest long-term threat emanating from the PRC.
    “Absent, too, was any substantive discussion of countering our adversaries’ alignment with deeper alliance relationships and more extensive defense industrial cooperation of our own.
    “This, of course, is due to change. As the 29th Secretary of Defense, Mr. Hegseth will be immediately tested by ongoing conflicts caused by Russian aggression in Europe and Iranian-backed terror in the Middle East. He will have to grapple with an unfinished FY25 appropriations process that – without his intervention – risks further harming the readiness of our forces.
    “By all accounts, brave young men and women join the military with the understanding that it is a meritocracy. This precious trust endures only as long as lawful civilian leadership upholds what must be a firewall between servicemembers and politics. The Biden Administration failed at this fundamental task. But the restoration of ‘warrior culture’ will not come from trading one set of culture warriors for another.
    “The single most important way for Secretary Hegseth to demonstrate his professed devotion to America’s warfighters will be to equip them – urgently – to deter aggression… and rebuild the defense industrial capacity to restock the depleted arsenal of democracy. In this cause, he will find willing partners on the Senate Appropriations Defense Subcommittee, which will expect and receive his candid testimony.
    “I wish Secretary Hegseth great success, and I look forward to working closely with him to restore American hard power. Every member of the uniformed services will be looking to him for decisive, principled, and nonpartisan leadership.”

    MIL OSI USA News –

  • MIL-OSI Banking: GlobalData tracks 40 years of innovation in FDA review designations

    Source: GlobalData

    GlobalData tracks 40 years of innovation in FDA review designations

    Posted in Pharma

    Regulatory authorities, particularly the US FDA, have played a crucial role in accelerating and incentivizing the development of innovative treatments through review designations. Since the first designation in 1984, the FDA has seen a substantial rise in the number of designations granted, reaching 694 in 2020. This surge reflects key pharmaceutical milestones, including the biotech boom and the advent of groundbreaking scientific advancements over the past four decades, observes GlobalData, a leading data and analytics company.

    Jasper Morley, Pharma Analyst at GlobalData, comments: “To date, the FDA has implemented seven different types of review designations, which accelerate and incentivize drug development. Each designation offers specific benefits to the drugmakers. For example, the orphan drug designation (ODD) is granted to drugs intended to treat a rare condition providing tax credits for qualified clinical trials, exemptions from user fees, and a potential of seven years market exclusivity following approval.”

    GlobalData’s report, “Pharmaceutical Review Designations – Trends and Industry Insights,” reveals that the FDA awarded its first 22 designations, consisting solely of ODD, in 1984. From 1984 to 1997, it awarded an average of only 23 designations per year, indicating limited adoption of review designations. However, between 1998 and 2012, an average of 93 designations were awarded yearly, and in 2012, the 182 review designations awarded was over 10 times the number awarded in 1997.

    This finding is aligned with the Modernization Act of 1997, whereby the FDA sought to speed up the approval of new drugs which saw the introduction of the fast-track and priority review designation types, in 1998 and 1999, respectively. Furthermore, this period also coincided with the advent of the biotech industry, whereby the 2003 completion of the human genome project catalyzed gene therapy developments.

    The period between 2012 and 2020 saw another rapid increase in the annual numbers of review designations awarded. Over this period, annual designations awarded by the FDA increased almost four-fold. This period included the implementation of novel designation types: qualified infectious disease product designation (in 2012), breakthrough therapy (2013), rare pediatric drug designation (2014), and regenerative medicine advanced therapy designation (2017).

    Morley adds: “The introduction of these specific designation types reflects the booming biotech industry, and embracing of novel technologies to develop advanced biologics, which began entering clinical development.”

    In 2020, the number of designations awarded reached a peak of 694. This reflected heightened pharmaceutical activity and investment during the COVID-19 pandemic, which accelerated the development of critical therapies and vaccines. Since 2020, the number of review designations has declined from this heady peak, with only 506 awarded in 2024. This decline is attributed to the return to the post-pandemic normality, whilst still maintaining historically high levels of activity compared to earlier decades.

    Morley concludes: “Since the introduction in 1984, the FDA has overseen increases in the annual awarding of review designations. This trend mirrors the evolution of the pharmaceutical industry, in terms of investment and utilization of novel technologies. Today, seven review designations remain an integral part of the FDA’s toolkit, expediting the approval of critical therapies and ensuring that life-saving drugs reach patients as quickly as possible.”

    MIL OSI Global Banks –

  • MIL-OSI Banking: Navigating Trump’s tariffs and social media key strategic priorities for retailers in 2025, says GlobalData

    Source: GlobalData

    Navigating Trump’s tariffs and social media key strategic priorities for retailers in 2025, says GlobalData

    Posted in Retail

    2025 will present significant challenges for retailers globally, as geopolitical issues and the disruptive force of AI continue, with the added challenge of navigating the impacts of the Trump administration, says GlobalData, a leading data and analytics company.

    GlobalData’s latest report, “Strategic Intelligence: Top Themes in Retail and Apparel 2025,” reveals that international trade and social media will be among the major themes impacting the retail sector in 2025.

    Sophie Mitchell, Retail Analyst at GlobalData, comments: “Trump’s proposed tariffs and tougher import tax regulations will cause major issues for retailers, especially those who operate highly globalized supply chains, adding significant import costs that will ultimately be passed on to the consumer. Solutions to this, including diversifying or localizing supply chains, will not happen overnight and come with their own costs, such as the higher cost of labor, which could again be passed on to consumers through higher retail prices.

    “Shein and Temu could be two of the biggest retailers to be hit by the measures, as for instance, Europe could also impose retaliatory tariffs to ensure it does not become the primary destination for Chinese goods as they are displaced from the US.”

    Something Trump has immediately taken action on is negotiations with China over TikTok. Trump’s pause on the ban on TikTok in the US indicates that he intends to reach a deal with its Chinese owner. However, the brief ban and prior noise around its implications have highlighted how essential a social media strategy centered around short-form video content with shoppable links, particularly on TikTok, is to driving retailers’ sales.

    GlobalData’s global survey of respondents in seven countries (US, France, Germany, Italy, Spain, China, and the UK) conducted in December 2023 found that 33.5% of consumers use TikTok (excluding China), making it the fourth most used social media app after Facebook, Instagram, and YouTube, overtaking X/Twitter*.

    Mitchell continues: “TikTok Shop provides a significant opportunity for retailers to convert usage and content consumption into sales, with consumers being able to discover and purchase products on one platform, whereas previously social content was primarily a brand awareness raising exercise.”

    TikTok has been particularly instrumental for retailers as it has allowed for the growth of micro-influencers, larger influencers, user-generated content, and brand/ retailer-generated content all in one platform due to the way the algorithm works. Retailers can take a 360-degree strategic approach to targeting consumers on the platform, with a combination of paid ads, organic reviews, and brand campaigns, convincing them to buy a product that they may not even have to leave the app to purchase.

    Mitchell concludes: “An effective social media strategy is essential for retailers in 2025, and should a permanent ban on TikTok come into effect in the US, retailers should pivot to other social media platforms that offer multi-pronged approaches to marketing and the ability to complete the shopping journey in-app, as TikTok’s efficacy has been proven.”

    *GlobalData’s 2023/24 Global Survey was conducted in December 2023 with 1,000 consumers per country

    MIL OSI Global Banks –

  • MIL-OSI Banking: South Korea bone graft and substitutes market to grow at 4% CAGR through 2033, forecasts GlobalData

    Source: GlobalData

    South Korea bone graft and substitutes market to grow at 4% CAGR through 2033, forecasts GlobalData

    Posted in Medical Devices

    The increasing prevalence of orthopaedic conditions such as osteoarthritis, osteoporosis, and trauma-related injuries is driving the need for innovative and efficient bone regeneration solutions. Against this backdrop, South Korea’s bone graft and substitutes market is set to grow at a compound annual growth rate (CAGR) of around 4% through 2033, says GlobalData, a leading data and analytics company.

    GlobalData’s report, “Bone Grafts and Substitutes Market Size by Segments, Share, Regulatory, Reimbursement, Procedures and Forecast to 2033,” reveals that South Korea held around 5% of the Asia-Pacific bone graft and substitutes market share in 2024.

    Jyoti Sharma, Medical Devices Analyst at GlobalData, comments: “Conventional bone graft products often face challenges such as insufficient adhesive strength and difficulties in maintaining their shape in complex cases. Novel products, such as injectable hydrogels, are expected to offer promising advancements by addressing these gaps and enhancing outcomes in bone defect management.”

    Researchers from South Korea-based Pohang University of Science and Technology (POSTECH) have recently developed an innovative injectable adhesive hydrogel for bone regeneration. This hydrogel utilizes visible light to simultaneously achieve cross-linking and mineralization. Its unique formulation, which includes alginate, mussel adhesive protein, calcium ions, and a photo initiator, ensured robust adhesion and structural stability in animal models with femoral bone defects.

    Sharma concludes: “Due to the growing nature of this market, the ongoing research is making significant efforts to address the challenges in bone defect management. While these solutions are still under development, once clinically validated, they have the potential to transform treatment approaches, improving patient outcomes and enhancing the quality of life for individuals affected by these conditions.”

    MIL OSI Global Banks –

  • MIL-OSI Banking: US pulsed field ablation market revenue surpasses $500 million in 2024, reveals GlobalData

    Source: GlobalData

    US pulsed field ablation market revenue surpasses $500 million in 2024, reveals GlobalData

    Posted in Medical Devices

    Pulsed field ablation (PFA) is a treatment for atrial fibrillation, an irregular heartbeat disorder, with a lower chance of damaging surrounding structures than previous methods. PFA uses electrical pulses that allow for a more targeted approach in order to only destroy abnormal tissue. PFA revenue exploded in Q1 2024 after FDA approvals for Boston Scientific’s FARAPULSE and Medtronic’s PulseSelect. Over the last year, the PFA market has grown to over $500 million, reveals GlobalData, a leading data and analytics company.

    In Q4 2024, Medtronic launched its new PFA device, the Affera Sphere-9, after receiving FDA approval in late October. In its first month, Sphere-9 made about half of the revenue that FARAPULSE made in its first month after approval, according to GlobalData’s US Healthcare Facility Invoicing Database. In December, two months after approval, Sphere-9’s revenue was at about a quarter of FARAPULSE’s revenue at the same point in its launch cycle.

    Amy Paterson, Medical Analyst at GlobalData comments: “Medtronic’s Sphere-9 launched at a lower price than Boston Scientific’s Farapulse originally did. It appears that Medtronic is intending to be price competitive with Boston Scientific in order to gain some of the market share.”

    Boston Scientific and Medtronic are currently the two major players in the PFA market. Boston Scientific dominated the market with the release of the Farawave in Q1 2024, despite PulseSelect’s earlier approval.

    Paterson adds: “Despite accumulating less revenue than the Farawave, Sphere-9 has doubled in sales in its second month after launch. So far, we have not seen this increase in sales have an impact on Boston Scientific sales, which currently hold the majority of the PFA market.”

    Paterson concludes: “It will be interesting to see if Medtronic is able to take over some of the market share that Boston Scientific has led since the beginning of 2024. As well, we will continue to monitor how new players like Johnson & Johnson’s Varipulse will shake up the market.”

    MIL OSI Global Banks –