Medical Device Network on MSN3d
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 ...
Medical Design & Outsourcing4d
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 Supra8d
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 ...
American Hospital Association3d
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 ...
MassDevice9d
FDA says Intuitive da Vinci 5 foot pedal recall is Class II
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...