The FDA granted 510(k) clearance of Zimmer Biomet's ROSA Shoulder System for robotic-assisted shoulder replacement surgery.
Philips is recalling the Panorama 1.0T HFO due to risk of explosion during a quench procedure caused by excessive pressure buildup.Read More
Perfuze announced FDA clearance for the Millipede 070 Aspiration Catheter and the second generation of the Millipede 088 Access Catheter.Read More
Senators Durbin and Blumenthal have requested the Government Accountability Office (GAO) to review the FDA’s policies on medical device recalls, citing the Philips Respironics case and a significant increase in recalls.Read More
A 57-year-old woman in Wisconsin accidentally discharged a concealed handgun while entering an MRI machine, sustaining a superficial gunshot wound, highlighting the potential dangers of metal objects in MRI environments.Read More
Despite a 115% increase in FDA recalls since 2018, MasterControl found that medical devices only contributed 4% of the total number.Read More
Atrium Health, a N.C.-based health system, has joined Mitre’s Medical Device Information Analysis and Sharing Public Private Partnership to collaboratively analyze medical-device-related data with stakeholders to enhance healthcare outcomes.Read More