Medical Device Network on MSN16h
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 ...
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.
FDA Recalls Nearly 200,000 Cans of Green Beans for Potential Contamination
Nearly 200,000 cans of green beans have been recalled by the U.S. Food and Drug Administration due to potential contamination ...
American Hospital Association2d
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 ...
Medical Device Network on MSN2d
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 ...
MassDevice10d
Sooma wins FDA IDE for neuromod tech that treats depression
Sooma announced that it received FDA investigational device exemption (IDE) for its transcranial direct current stimulation ...
Manila Standard11d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...
BioSpace16d
MedRhythms Announces FDA Class II Listing for Movive™ to Support Gait Rehabilitation and Motor Function for Parkinson’s Disease
the company’s neurorehabilitation system to support gait rehabilitation and motor function in adults with Parkinson’s disease (PD), has been listed as a Class II, Rx-only medical device with the U.S.
Modern Healthcare16d
FDA labels Philips' recall of Tack Endovascular Systems a Class I
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...
FierceBiotech17d
FDA elevates endovascular recall as Philips pulls Tack implant from the market
The FDA subsequently categorized the recall as Class I, its most serious, with about 3,000 systems distributed across the U.S. and Europe. Philips acquired the Tack system through its $360 million ...
Forbes18d
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The Food and Drug Administration (FDA) published new guidance for AI-enabled medical devices on January 7, 2025. These are nonbinding and not for implementation. The public comment window for ...