Enforcement & Litigation

This week, Medtronic said it would pay $738m for insulin patch firm EOFlow; Neuralink got an FDA OK for first-in-human trials; and UK agency NICE backed genetic tests for stroke patients and digital therapeutics for mental health conditions.

The White House Office of Science and Technology Policy has released an updated national strategic framework outlining priorities and goals for federal investment in AI. Industry executive Peter Shen weighs in on the plan.

The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June. 

An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.  

After consulting with the US FDA, Integra Life Sciences initiated a recall of products produced in its Boston Facility. The company expects losses of $22m.

Several updates have come in recent weeks on the European Commission’s planned new Regulation on HTA, including a list of stakeholder members and updated rolling timeline. Medtech Insight explains how and when this legislation will affect the medtech sector.

John Villafranco, partner at Kelly Drye & Warren LLP, says the US FTC’s ability to obtain monetary relief using the penalty offense mechanism is questionable both on statutory and Constitutional grounds. Marketers faced with civil penalties – for example, for alleged inadequately substantiated health claims – should stand their ground, he suggests in a recent interview.

This week, the DC Attorney General announced a settlement with ovulation-tracking app Premom; a novel scoliosis treatment won FDA approval; research showed Fractyl Health’s Rejuva delivery system can deliver gene therapy directly to the pancreas; and BearCare recalled a thermometer over burn risks.