Medical Device Network on MSN9d
FDA tags Medtronic embolisation device recall as Class I
Medtronic initiated the recall of certain Pipeline Vantage embolisation devices in January 2025 following reports of four ...
Fierce Biotech1d
FDA's novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
STAT1d
New tests for Alzheimer’s and cancer get FDA’s ‘breakthrough’ status
PathChat, a new AI model for pathology made by Modella AI, received breakthrough status in January. The device can digest ...
Medical Design & Outsourcing10d
De-risking medical device startups with a systematic approach to innovation
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
JD Supra14d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
Forbes25d
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The Food and Drug Administration (FDA) published new guidance for AI-enabled medical devices on January 7, 2025. These are nonbinding and not for implementation. The public comment window for ...
American Hospital Association9d
FDA issues recall on Medtronic embolization devices
The Food and Drug Administration has identified a Class I recall of Medtronic Neurovascular 027 Compatible Pipeline Vantage ...