An FDA advisory panel voted against a favorable recommendation for BD‘s Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA’s Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of effectiveness. The […]
Pre-Market Approval (PMA)
EUAs help push FDA to record novel-device nods in 2020
The FDA approved, cleared or authorized a record high of 132 novel medical devices in 2020, with pandemic-related emergency use authorizations (EUAs) adding significantly to the total. That compares with 29 novel devices the agency authorized in 2010, according to a new article by officials from the agency’s Center for Devices and Radiological Health (CDRH). […]
FDA approves low-profile aneurysm embolization system
Terumo (TYO:4543) subsidiary MicroVention announced today that it received FDA approval of a PMA supplement for its WEB 17 system. Aliso Viejo, Calif.-based MicroVention’s WEB 17 system is a new addition to its WEB aneurysm embolization system for treating intracranial wide-neck bifurcation aneurysms, according to a news release. WEB 17 features a lower profile delivery system compatible […]
FDA panel advises against assurable effectiveness of Neovasc Reducer
Neovasc (NSDQ:NVCN) announced that an FDA advisory panel voted against reasonable assurance of effectiveness for its Reducer system. The FDA’s Circulatory System Devices Advisory Panel voted 1 to 17 “against” on the issue of “a reasonable assurance of effectiveness,” according to a news release. “We would like to thank the FDA, the panel and members of […]
Fresenius wins FDA approval for next-gen dialysis solution bags
Fresenius Medical Care North America (NYSE:FMS) recently announced that FDA has approved its Deleflex peritoneal dialysis solutions bagged in its less wasteful Biofine material. Company officials expect the new Biofine peritoneal solutions bag to be first available to a limited number of patients in the U.S. this fall. “The new Biofine peritoneal dialysis solutions line is […]
J&J wins FDA approval for ablation catheter
Johnson & Johnson (NYSE:JNJ) recently announced that its Biosense Webster business has secured FDA approval for its Thermocool SmartTouch SF ablation catheter. The Thermocool SmartTouch received approval for the treatment of persistent atrial fibrillation, J&J announced yesterday. Get the full story on our sister site Medical Tubing + Extrusion.
CDRH director Shuren says flexibility remains key as COVID-19 strains regulatory system
Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), believes the level of flexibility shown by the FDA during the COVID-19 pandemic may be needed in a post-pandemic world. Speaking in a town hall event at The Virtual Medtech Conference hosted by AdvaMed, Shuren outlined the work the FDA has put […]
Advisory panel to vote on FDA approval of Neovasc Reducer
Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval. The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a […]
FDA approves Medtronic MiniMed 770G insulin pump for young children
The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for such young children, according to the agency. The FDA approved an earlier MiniMed […]
TransMedics to get its virtual day with FDA panel on heart transplant tech
After a six-month pandemic-related delay, TransMedics (NSDQ:TMDX) is set to have an FDA panel review the premarket approval application for its donor heart transport technology on October 7, 2020. TransMedics’ organ care system (OCS) technology is designed to keep donated hearts, lungs and livers in near-living condition until transplantation. The FDA approved the Andover, Mass.-based company’s […]
FDA approves Edwards Lifesciences’ ready-to-implant aortic valved conduit
Edwards Lifesciences (NYSE:EW) announced today that FDA has approved its Konect Resilia aortic valved conduit (AVC). Edwards describes the Konect Resilia as the first ready-to-implant option for bio-Bentall procedures, a complex surgery that involves the replacement of a person’s aortic valve, aortic root and the ascending aorta. Surgeons find themselves having to perform nearly a third […]
