HHS' FY 2004 budget request will likely seek to rectify a potential shortfall in funds needed to sustain FDA's device user fee program through FY 2007
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A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.
The value proposition of surgical robots is quickly changing. Gone is the focus on benefit to patients; instead cost, operative efficiency and surgeon longevity are the new focal points, making deciphering M&A value much more difficult.
Medicare’s device coverage process is “a system in crisis,” consultant Bruce Quinn warned at the NextGen Dx Summit. He criticized bloated NCDs, stalled advisory committees, and years-long delays, urging CMS to streamline LCDs and adopt a six-month “fast-track” model to speed innovation access.
