FDA – Medwire

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FDA – Medwire

FDA

Navigating regulatory landscapes to bring safer, smarter healthcare solutions to life.

Dexcom Taps Jake Leach as Next CEO

FDA Approves First Neuroimmune Device for Arthritis

EvoEndo Gains FDA Nod for All-Ages Gastroscope

Medtronic Advances Toward FDA Approval for Infuse Bone Graft in...

Dexcom Taps Jake Leach as Next CEO

Dexcom Taps Jake Leach as Next CEO

Dexcom has announced that President and COO Jake Leach will become CEO on January 1, 2026, succeeding longtime leader Kevin Sayer. Leach, a 21-year Dexcom veteran, has been instrumental in developing multiple generations of...

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FDA Approves First Neuroimmune Device for Arthritis

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EvoEndo Gains FDA Nod for All-Ages Gastroscope

EvoEndo Gains FDA Nod for All-Ages Gastroscope

Medtronic Advances Toward FDA Approval for Infuse Bone Graft in TLIF

Medtronic Advances Toward FDA Approval for Infuse Bone Graft in...

Stereotaxis Wins FDA Clearance for Magic Sweep Robotic EP Mapping Catheter

Stereotaxis Wins FDA Clearance for Magic Sweep Robotic EP Mapping...

FDA Warns on Baxter Infusion Pump Safety

FDA Warns on Baxter Infusion Pump Safety

Imperative Care Gains FDA Clearance for Zoom 7X Catheter

Imperative Care Gains FDA Clearance for Zoom 7X Catheter

FDA Grants IDE for UroMems’ Smart Implant Study in Male SUI

FDA Grants IDE for UroMems’ Smart Implant Study in Male...

FDA Expands Watchman Device Use for Post-Ablation

FDA Expands Watchman Device Use for Post-Ablation

FDA Announces Multiple Class I Recalls for Edwards Lifesciences Cardiac Cannulae

FDA Announces Multiple Class I Recalls for Edwards Lifesciences Cardiac...

FDA Approves Bayer’s Finerenone for Broader Heart Failure Treatment

FDA Approves Bayer’s Finerenone for Broader Heart Failure Treatment

Johnson & Johnson’s Varipulse PFA Platform Gets FDA Update

Johnson & Johnson’s Varipulse PFA Platform Gets FDA Update

Synchrony Medical Secures FDA Clearance for LibAirty Airway Clearance System

Synchrony Medical Secures FDA Clearance for LibAirty Airway Clearance System

Johnson & Johnson MedTech Updates FDA Clearance for Varipulse PFA System

Johnson & Johnson MedTech Updates FDA Clearance for Varipulse PFA...

FDA Issues Warning on J&J Automated Impella Controller After 3 Deaths

FDA Issues Warning on J&J Automated Impella Controller After 3...

FDA Grants Breakthrough Therapy Designation to Lexeo’s LX2006 for FA Cardiomyopathy

FDA Grants Breakthrough Therapy Designation to Lexeo’s LX2006 for FA...

InspireMD Launches FDA-Approved CGuard Prime Carotid Stent in U.S.

InspireMD Launches FDA-Approved CGuard Prime Carotid Stent in U.S.

Caranx Medical’s TaviPilot AI Wins FDA Clearance

Caranx Medical’s TaviPilot AI Wins FDA Clearance

Moon Surgical Secures FDA Clearances for Maestro Robot Enhancements

Moon Surgical Secures FDA Clearances for Maestro Robot Enhancements

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