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", ...
Medtronic slips after FDA notice on product recall
Medtronic (MDT) stock turned lower as the FDA announced a most serious type of recall involving its Pipeline Vantage 027 ...
FDA issues Medtronic embolization device recall and correction notice
In a notice posted to the agency’s website, the FDA noted that on January 30, 2025, Medtronic (MDT) Neurovascular sent all affected customers ...
MedTech Dive16 小时
Top device firms report safety data late: BMJ
BD, Medtronic and Abbott were among the top 10 medical device manufacturers with the highest number of late reports, the ...
US health agencies announce plan to strengthen domestic infant formula supply
The U.S. FDA and HHS announced on Tuesday a set of actions and initiatives focused on infant formula to ensure the ongoing quality, safety, nutritional adequacy and resilience of the domestic infant ...
MedPage Today on MSN6 天
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
Medical Design & Outsourcing4 天
Medtronic’s RDN GM shares reimbursement advice and his ‘airplane moment’
Medtronic VP Jason Fontana offered advice for other device developers who might one day be looking for their own NCA.
GlobalData on MSN1 天
FDA adds haemodialysis tubes to shortage list amid supply issues
The US Food and Drug Administration (FDA) has added haemodialysis bloodlines to its medical device shortages list amid supply ...
GlobalData on MSN5 天
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
Scientific American17 小时
New Form of Parkinson’s Treatment Uses Real-Time Deep-Brain Stimulation
Current FDA approval of this adaptive system is for the treatment of Parkinson’s only, not essential tremor, dystonia (a ...