Enforcement & Litigation

The US FDA is reporting dozens more additional deaths associated with a May recall of Philips ventilators than initially reported. The company says it stands by its original number of seven and has reached out to the FDA.

A Friday Supreme Court ruling could create uncertainty for the medtech industry by giving judges more latitude to overrule executive-branch decisions. While some pro-business groups applauded the decision, others saw risks as well as benefits.

This week, Boston Scientific agreed to pay $1B+ for stroke prevention device firm Silk Road Medical; the FDA asked for feedback on patient safety for non-device medical software; and a former medtech CEO was sentenced to six years for her part in a phony device scheme.

The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

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. 

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. 

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.

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.  

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.

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.

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.

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.

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.

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

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.

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.