(CNBC) – The Food and Drug Administration has cleared a new artificial intelligence-powered X-ray device that maker GE Healthcare says reduces the time to detect a collapsed lung from eight hours to as little as 15 minutes. […]
Medivis announced today that its groundbreaking augmented reality (AR) technology platform for surgical applications, SurgicalAR, has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration. […]
EpiBone, today announced that the U.S. FDA has granted its Investigational New Drug clearance to proceed with a Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial (EB-CMF), as a potential treatment for ramus continuity defects in the mandible. […]
(STAT) – The Food and Drug Administration announced Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data. […]
Zimmer Biomet, a global leader in musculoskeletal healthcare, today announced U.S. FDA 510(k) clearance of the ROSA® ONE Spine System for robotically assisted minimally invasive and complex spine surgeries, strengthening the Company’s comprehensive ROSA® ONE Brain and ROSA® Knee portfolio. […]
(KHN) – The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark. […]
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