FDA

FDA developing new rules for artificial intelligence in medicine

April 3, 2019

(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 Receives FDA Clearance of ROSA® ONE Spine System for Robotically-Assisted Surgeries

March 25, 2019

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. […]

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

March 7, 2019

(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. […]

Zimmer Biomet Receives FDA Clearance for ROSA® Knee System for Robotically-Assisted Surgeries

January 25, 2019

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. […]

PeekMed® receives FDA 510(k) clearance to take its orthopedic planning system into the US market

December 12, 2018

PeekMed reached 510(k) clearance for its orthopedic planning system, from the FDA, after regulatory approval in the European Union, and successfully working with more than 1100 surgeons. […]

Novarad’s OpenSight Augmented Reality System is the First Solution for Microsoft HoloLens 510(k) Cleared by the FDA for Medical Use

October 30, 2018

The OpenSight® Augmented Reality System is the first AR medical solution for Microsoft HoloLens cleared by the FDA receiving 510(k) clearance for use in pre-operative surgical planning. […]