
DeepQure wins FDA IDE nod for renal denervation study
DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system.

DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system.

CroíValve today announced favorable patient outcomes in a first-in-human clinical trial of its Duo tricuspid coaptation valve system.

Johnson & Johnson MedTech‘s DePuy Synthes announced today that it received a new FDA 510(k) clearance for its Velys surgical robot platform.

Mequ announced today that the FDA granted 510(k) clearance to its M Warmer system, a portable blood and IV fluid warmer platform.

Amplitude Vascular Systems announced today that it received FDA investigational device exemption (IDE) for its pulsatile intravascular lithotripsy (PIVL) therapy.

Abbott (NYSE: ABT)+ announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system.

Enspectra Health, a health tech company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its next generation AI-powered VIO™ Skin Platform (VIO)

FloPatch from Flosonics Medical provides real-time patient data to enhance clinical decision-making during life-saving critical care events

YOKNE’AM ILLIT, Israel, June 5, 2024 /PRNewswire/ — Lumenis Be. Ltd., a leading energy-based medical device company for aesthetic and eye care solutions, is proud to announce the launch of its breakthrough laser system designed to combat hair loss. Recently cleared by the Food and Drug Administration (FDA), FoLix becomes the first and only fractional laser choice for safe, effective, and natural hair loss treatment for women and men in the United States.

Moon Surgical announced today that it received FDA clearance for the commercial version of its Maestro surgical robot system.