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Enforcement & Litigation

Set Alert for Enforcement and Legislation

US FDA May See Second Straight Year of Non-User Fee Funding Cuts From Congress

The House Appropriations Agriculture, Rural Development, and FDA Subcommittee advanced the FDA’s fiscal year 2025 funding bill, beginning a likely long and difficult budget cycle. 

FDA Legislation

Flat-Lining US FDA: Failure To Invest May Have Consequences

Old habits die hard when it comes to funding the FDA. When the agency is doing things well, it doesn’t get the money it needs to keep up the momentum. 

Legislation User Fees

3 Deaths Linked To Latest Teleflex Catheter Recall

Teleflex is recalling thousands of intra-aortic balloon catheter kits that are used during cardiac procedures and to treat complications from heart failure. This is the latest in a series of recalls from Teleflex and its subsidiary Arrow International.

FDA Recalls

News We’re Watching: DMCA Judicial Review Upheld; Abbott’s Rio CGM Available OTC; J&J’s Velys Wins FDA UKA Expansion

This week, AdvaMed and MITA win appeal to prevent repair companies from hacking medical devices, the FDA cleared Abbott’s Libre Rio CGM for OTC sales, J&J MedTech wins expanded clearance for Velys knee medical robot, the FDA updates its AI program, Canary Speech secures $13m in series A funding and Xeltis won FDA approval for an IDE submission to begin enrolling patients for a pivotal study for aXess.  

News We're Watching Approvals

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

News We’re Watching: Medtronic Recall, More Chinese Syringe Woes, Surgical Robot Clearance

This week, Medline announced recalls of tracheal tubes; Eko Health raised $41m in Series D funding; and the US FDA announced participation in collaborative communities focused on brain-computer interface devices and more.

Approvals FDA

FDA Implements Authority To Destroy Certain Medical Devices, Amends Final Rule To Provide Device Owners Prior Notification

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

FDA Enforcement

NAD Oddball: Thermometer Case Administratively Closed As Advertiser Takes Matter To Federal Court

Exergen seeks a declaration from Massachusetts federal court that claims challenged by Baxter in the National Advertising Division forum regarding the accuracy of its thermometers do not constitute false or misleading advertising, if they are even advertising at all.

Advertising, Marketing & Sales Legal Issues

Sen. Paul Leads Effort To Halt FDA’s LDT Final Rule

The Kentucky Republican says the final rule is an overreach by the FDA and will harm patient access to crucial diagnostics, as well as slowing innovation in the sector.

Policy Politics

News We’re Watching: Panel Backs Guardant Shield, EU Adopts AI Act, Magellan Settles Lead Test Claims

This week, an FDA advisory panel recommended approval of the Guardant Shield blood test for colon and rectal cancers; the EU Council signed off on the world’s first AI law; and the FDA challenged innovators to develop AI/ML technologies to detect gait freezing in individuals with Parkinson’s disease

Regulation Commercial

European Parliament Proposes Radical Changes For The Recertification Of Medical Devices

Just as concerns are growing in the sector about how notified bodies will manage simultaneous surges in requests for recertification and legacy devices around 2027/28, the European Parliament has launched a key initiative.

Regulation Policy

Telehealth Experts Discuss Access In Health Care Deserts, Overcoming Provider Resistance, Liability Concerns

Virtual care leaders at Providence and Sanford Health shared successes and challenges in implementing remote monitoring and telehealth programs during a panel discussion at the recent Reuters Digital Health conference in San Diego.

Digital Health Telehealth

Pair Of Deaths Linked To Latest Recall Of Abbott HeartMate Pump

Abbott has issued a recall of several hundred HeartMate 3 pumps used to support patients with heart failure after reports of blood leakage and air entering the devices.

FDA Recalls

News We’re Watching: Telehealth Advances; AI Regulation; NIH Backs SIRT; Oura Upgraded

This week, a House subcommittee advanced a two-year telehealth extension, Chuck Schumer and a bipartisan group of senators introduced a plan for regulating AI, the FDA launched its new online RST Catalog, NIH recommends targeted radiotherapy cancer treatment, and Oura announced new health features for its smart ring.

News We're Watching Artificial Intelligence

FDA Medical Product Communications Need More Nuance To Deter Misinformation, Experts Say

Government agencies and others need to improve their communication to a broad audience about the relative safety of vaccines, as well as current scientific uncertainty, experts said at the FDLI annual meeting.

FDLI Legal Issues

Shuren: CDRH Needs More Funding For Active Surveillance, Supply Chain Monitoring

In a Tuesday webinar from the Alliance for a Stronger FDA, CDRH head Jeffrey Shuren said that a “politicized and toxic” environment in Washington could limit the agency’s ability to keep up with innovation and responding to new threats.

FDA Leadership
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