The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.
The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.
One of the documents provides recommendations relating to premarket notification submissions (ie the “510(k)” process)2; the other contains recommendations on...
Terumo will acquire OrganOx for about $1.5bn, adding the only FDA-cleared liver normothermic perfusion device to its portfolio. Analysts don’t expect the buyout to have a significant impact on competition, but the deal marks a strategic shift for Terumo into transplant medicine.
A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.
Medicare’s device coverage process is “a system in crisis,” consultant Bruce Quinn warned at the NextGen Dx Summit. He criticized bloated NCDs, stalled advisory committees, and years-long delays, urging CMS to streamline LCDs and adopt a six-month “fast-track” model to speed innovation access.
