Medical Device Network46 分钟
FDA tags Medtronic embolisation device recall as Class I
The US Food and Drug Administration (FDA) has tagged Medtronic’s recall of certain Pipeline Vantage embolisation devices as ...
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 ...
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 ...
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", ...
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 Dive21 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 ...
Scientific American22 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 ...
The Manila Times23 小时
AI in Remote Patient Monitoring Market worth US$8,438.5 million by 2030 with 27.5% CAGR ...
The global AI in Remote Patient Monitoring Market, valued at US$1551.8 million in 2023, is forecasted to grow at a robust CAGR of 27.5%, reaching US$1967.7 million in 2024 and an impressive US$8438.5 ...
Nearly a third of FDA medical device adverse events reported late: study
Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
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.
The BMJ6 天
Late adverse event reporting from medical device manufacturers to the US Food and Drug ...
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 ...
MedPage Today6 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.