Medtronic (NYSE:MDT) announced today that it received FDA approval for its Pipeline Flex embolization device with Shield Technology. Fridley, Minn.–based Medtronic’s Shield Technology is a proprietary platform designed to advance flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material […]
Pre-Market Approval (PMA)
FDA grants IDE approval for Cerus Endovascular’s Contour Neurovascular System clinical study
Cerus Endovascular announced today that it received FDA investigational device exemption for a trial for its Contour Neurovascular System. Fremont, Calif.–based Cerus’ Contour Neurovascular System is designed to treat intracranial aneurysms. Its creators made it of fine mesh braid to target the neck of the aneurysm away from the vulnerable dome. It’s possible to self-anchor […]
FDA advisory committee positive about TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System. The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable […]
FDA approves Medtronic’s Harmony transcatheter pulmonary valve system
FDA has approved a Medtronic device described as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation — a condition often arising from congenital heart disease. The Harmony transcatheter pulmonary valve system could delay the time before someone with congenital heart disease might need additional open-heart surgery, FDA said today. The Harmony device […]
FDA permits marketing of first COVID-19 diagnostic test through premarket review process
The FDA announced that it granted marketing authorization to Biomérieux subsidiary BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test. Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the de novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according […]
Abbott launches real-time remote neuromodulation tech
Abbott (NYSE:ABT) announced today that the FDA has approved a neuromodulation treatment platform that allows physicians to communicate with patients and monitor or change their treatment in real-time. The NeuroSphere Virtual Clinic could increase access to treatment for patients with chronic pain or movement disorders who don’t live close to a care provider, have difficulty accessing […]
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
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 […]
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 […]
