The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency's Safer Technologies Program. FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of … [Read more...] about FDA clears first device authorized under Safer Technologies Program
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FDA clears Lightning Flash thrombectomy system from Penumbra
Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system. Alameda, California-based Penumbra also initiated the launch for the system. The company called Lightning Flash "the most advanced and powerful mechanical thrombectomy system on the market." Lightning Flash features the … [Read more...] about FDA clears Lightning Flash thrombectomy system from Penumbra
FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions … [Read more...] about FDA approves Medtronic drug-eluting stents for treating bifurcation lesions
FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota–based Medtronic's In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral … [Read more...] about FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter
Abbott imaging catheter recall flagged as Class I by FDA
The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall. That's the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11. The recall affects … [Read more...] about Abbott imaging catheter recall flagged as Class I by FDA
FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, … [Read more...] about FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
FDA warns of potential toxic risk from Fresenius hemodialysis machines
The FDA is evaluating the risk of exposure to toxic chemicals from silicone tubing used in Fresenius Medical Care (NYSE: FMS) hemodialysis machines. The investigation concerns three models of Fresenius hemodialysis machines: the 2008T, 2008K2, and 2008K. The chemicals — non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL … [Read more...] about FDA warns of potential toxic risk from Fresenius hemodialysis machines
Recall of Medtronic’s Harmony delivery catheter is Class I
The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system. Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a … [Read more...] about Recall of Medtronic’s Harmony delivery catheter is Class I
Getinge intra-aortic balloon pump recall is Class I
The FDA determined that Getinge's recall of its Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind. Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in … [Read more...] about Getinge intra-aortic balloon pump recall is Class I
ALung Technologies wins FDA de novo nod for Hemolung respiratory assist system
ALung Technologies announced today that it received FDA de novo clearance for its Hemolung respiratory support platform. Pittsburgh-based ALung designed its Hemolung system to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) for patients with acute respiratory failure. Get the full story at our sister site, MassDevice. … [Read more...] about ALung Technologies wins FDA de novo nod for Hemolung respiratory assist system
