User Fee Negotiators Far Apart: Industry Seeks To Delay New Fee Levels Until FDA Improves Performance

Device industry reps say industry-paid FDA user fees should be reauthorized for only two years, not five, to allow ongoing changes to FDA's pre-market review programs to sink in before a more meaningful user fee package is passed.

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Expert Panels Remain Tough On Manufacturers And Their Notified Bodies

 

The EU’s extra layer of checks on clinical evidence is proving a difficult, and sometimes humiliating process, for many device companies whose products have come under the spotlight.

Rising Oncology Start-ups Recognized For Breakthrough Cancer Research

 

The Cancer Research Horizons Innovation Awards took place on July 10. Medtech Insight spoke to nominees for the women’s entrepreneur of the year award: Mireia Crispin-Ortuzar, CEO of 52 North Health; Anita Grigoriadis, CEO of PharosAI; and Maria Giovanna Lizio, Founder of WILD-Imaging Technology.

HeartFlow Takes Another Crack At Public Markets With $100M IPO Filing

 
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AI heart imaging company HeartFlow filed for a $100m IPO after scrapping its 2022 SPAC plans. It remains unprofitable but is betting on FDA clearances, Medicare coverage and a demand for AI-powered diagnostics to win over investors.