FDA Gets Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Breakdown
The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.
The FDA updated a safety communication regarding medical device reports associated with the breakdown of materials used in Philips devices.
Linear Health Sciences received U.S. FDA clearance and Health Canada approval of its tension-activated breakaway safety release valve.
One member of the HTM sector believes that Congressional efforts to clarify the definition of medical device “remanufacturing” should be welcomed by all biomeds. He lays out his argument here.
The new bipartisan House bill would require medical OEMs to make parts, tools, and repair manuals available to powered wheelchair owners.
The U.S. FDA issued a draft guidance that is intended to describe its policy on its participation in the Voluntary Improvement Program.
The Joint Commission appointed Haytham Kaafarani, MD, MPH, FACS, as its new chief patient safety officer and medical director.
The IMDRF drafted a proposed guidance that seeks to protect legacy medical devices from cyberattacks.