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regulatory

FDA
MedTech

FDA formally kicks off medical device user fee negotiations

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews.
Conor Hale Aug 4, 2025 4:45pm
Mendaera Focalist robot

Mendaera scores FDA clearance for handheld needle robot system

Jul 9, 2025 10:30am
FDA Commissioner Martin Makary speaking at the FDLI conference in Washington DC

Martin Makary outlines AI plans, broad vision for FDA leadership

May 15, 2025 12:00pm
head and brain

Imperative Care launches dual-catheter stroke aspiration system

May 9, 2025 10:00am
heart monitor

Element Science’s wearable defibrillator patch wins FDA approval

May 5, 2025 11:09am
Precision Neurosciences Layer 7

FDA clears Precision Neuro’s brain-computer interface implant

Apr 17, 2025 11:00am

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