GlobalData 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 Device Network on MSN1d
FDA tags Becton, Dickinson and Company infusion software recall as Class I
Problematic software has been the cause of multiple infusion pump recalls in the medical device industry over the past few ...
FDA Recalls Nearly 200,000 Cans of Green Beans for Potential Contamination
The U.S. Food and Drug Administration issued a Class II recall notice to take back 8,242 cases (197,808 cans) of Good & ...
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 ...
Medtronic recalls aneurysm-treating device linked to four deaths
The FDA recall affects more than 25,000 of the Fridley-run company’s devices and follows reports of 17 injuries.
GlobalData on MSN8d
FDA approves early feasibility study of Valcare’s transcatheter device
The FDA has approved Valcare Medical’s IDE application, allowing it to begin an EFS of Amend Trans-Septal System.
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 ...
South Wales Argus on MSN10h
Man arrested over class A drug offences following early-morning raid
A man has been arrested over a series of drug offences following a successful early morning warrant carried out by police ...
Manila Standard12d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
The BMJ10d
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...