FDA granted marketing authorization to the BioFire SARS-CoV-2 test using the de novo pathway.

The use of artificial intelligence in medical devices is on the rise. Although there is no specific directive or regulatory framework yet, AI decisions still need to be understandable and verifiable to ensure patient safety. TÜV SÜD shares key...

Integrating quality into medical device product development and elsewhere is an issue of mindset rather budget, says Jon Speer, founder of Greenlight Guru.

FDA alerted labs and providers that positive results can occur with the Roche test designed to detect COVID-19 and influenza A/B.

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The federal agency issued warning letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd., and Thermavis.

ASTM has published F3502-21, a standard specification for general-purpose face coverings, which could help consumers understand covering filtration efficiency and more.

Medtronic is recalling the pump implant kit for its HeartWare Ventricular Assist Device two deaths and many serious injuries were reported. This is the company's second HeartWare-related recall in about a year, and one of several in the device's...

Members of the Sterilization Packaging Manufacturers Council share how patient safety prompted the idea for Sterile Packaging Day—as well as the council’s overall mission.

Hominis is also the first robot-assisted surgical device with arms designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow, and wrist joints, allowing the robot to access and reach through areas not possible...