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regulatory

Mendaera Focalist robot
MedTech

Mendaera scores FDA clearance for handheld needle robot system

The Fierce 15 winner aims to tap into some of the most common procedures performed today—about 200 million per year—with a new category of robotics.
Conor Hale 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
FDA stop sign

FDA's novel device clearances slow to a crawl

Mar 27, 2025 11:30am

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