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Healthcare Technology

AI and software as a medical device, digital health, surgical robotics and connected devices, and where regulators draw the line.

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Three people in business attire speak into microphones held out by reporters in a conference room Spotlight CorTec Lands Second FDA Breakthrough Nod for BCI Sep 18, 20266 min read Read the story A woman leans over a desk signing an official document while a colleague looks on in a bright office Guidance & Policy FDA Denies Bid to Exempt Radiology AI From 510(k) Sep 18, 20265 min read Read the story Colleagues seated at a conference table with microphones review documents during a panel discussion Devices & Diagnostics FDA Clears First Robotic LigaSure Vessel Sealer Sep 17, 20264 min read Read the story An office worker stamps an official document at a desk Devices & Diagnostics FDA Breakthrough Status for Remote Robotic Stroke Device Sep 16, 20266 min read Read the story A man in a navy suit sits at a wood desk reviewing a printed document, with a U.S. flag and bookshelf of framed certificates behind him Guidance & Policy FDA Names Permanent CDER, CBER Chiefs, New AI Post Sep 12, 20265 min read Read the story Two professional women in coats stand on courthouse steps discussing a document held in a black folder Guidance & Policy MHRA Panel Proposes 'L-Plates' for AI in Healthcare Sep 12, 20264 min read Read the story Two gowned staff walking and reviewing notes together in a bright cleanroom corridor Devices & Diagnostics FDA Clears Spineart's Robotic Spine Screw App Aug 26, 20264 min read Read the story The Texas State Capitol dome against a clear blue sky, with the American and Texas flags flying from an adjacent rooftop Devices & Diagnostics FDA Clears Abbott's Libre Duo Glucose-Ketone Monitor Aug 25, 20265 min read Read the story The gold dome of the Georgia State Capitol building rises against a partly cloudy blue sky Devices & Diagnostics FDA Clears Tempus's AI Tool for Pulmonary Hypertension Aug 25, 20264 min read Read the story Two lab specialists in white coats and safety glasses examine a blood-collection tube in a clinical laboratory Devices & Diagnostics FDA Authorizes First Robotic Blood-Draw Device Aug 20, 20266 min read Read the story The US Supreme Court building with cherry blossoms and an American flag under a clear blue sky Guidance & Policy FDA Weighs a Competency Test for AI Medical Devices Aug 19, 20265 min read Read the story Two masked, gowned laboratory researchers in a cleanroom review a sample slide loaded on a light microscope Devices & Diagnostics FDA Lets Proscia Add Scanners Without New 510(k)s Aug 6, 20265 min read Read the story Loose orange, pink, and yellow tablets scattered across a light gray surface, softly out of focus Guidance & Policy MHRA Draws the Line on AI Scribes as Medical Devices Jul 29, 20265 min read Read the story Three men in business suits stand at a lectern with a U.S. flag behind them, one gesturing as he speaks Devices & Diagnostics FDA Picks Dexcom as First TEMPO Pilot Participant Jul 24, 20266 min read Read the story