A survey of Minnesota device executives released last week closely aligns with previous industry polls, but the timing is notable: it comes just as Congress is completing passage of a user fee reauthorization bill championed by national device groups.
Washington device lobbyists are championing the impending enactment of FDA user fee reauthorization as a major win in the effort to improve FDA’s pre-market review process, but some Minnesota-based firms signaled last week that they are decidedly less sure of that.
Results of a survey of 59 Minnesota medical technology CEOs and venture capitalists released by an industry alliance June 19 indicate that many executives in the state, where...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
