FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
'Watershed moment': Experts call for hyperbaric chamber regulations after child's death
Industry leaders say the government failed to protect Thomas Cooper, 5, from dying in a hyperbaric chamber fire at the Oxford ...
JD Supra6d
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 ...
Medical Design & Outsourcing2d
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 ...
IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer
IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive ...
Med Device Online3d
Key QMS Considerations For Your Medical Device Startup
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...
Medtronic slips after FDA notice on product recall (update)
Medtronic (MDT) stock turned lower as the FDA announced a most serious type of recall involving its Pipeline Vantage 027 ...
Master FDA Inspection Compliance: Join the Virtual FDA Inspection Preparedness Training (May 7-8, 2025)
Join the FDA Inspection Preparedness & Compliance Online Training (May 7-8, 2025) to master regulatory inspection readiness for pharma, biotech, biologics, and medical device industries. This ...
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 & ...
In wake of child's death, industry leaders call for regulation of hyperbaric chambers
Industry leaders say government failed to protect Thomas Cooper from dying in a hyperbaric chamber fire at the Oxford Center ...
Medical Dialogues8h
Prioritize healthcare security through balanced tariff measures for medical devices: AiMeD urges Govt
AiMeD suggested India implement similar duties to protect the medical device supply chain and prepare for future health ...