Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA premarket approval for its r-SNM sacral neuromodulation system for the treatment of overactive bladder and urinary retention. The implantable, rechargeable sacral neuromodulation device is the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device […]
Neovasc to pursue PMA this year for Reducer
Neovasc (NSDQ:NVCN) said today that it plans to seek pre-market approval from the FDA for its Reducer angina device by the end of the year. In July, Vancouver-based Neovasc said it hoped the get the device on the U.S. market in early 2020 via a humanitarian device exemption. Reducer is designed to narrow the coronary sinus […]
Medtronic bids for FDA approval of OAB/FI neuromodulation device
Medtronic (NYSE:MDT) said today that it filed a pre-market approval supplement with the FDA for its InterStim Micro neurostimulator and its InterStim SureScan MRI leads. The InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to send electrical impulses to sacral nerves and normalize connections between the brain, bladder and bowel for treating patients with […]
FDA requires more postmarket data to keep certain devices on the market
The FDA would require medtech companies seeking certain premarket approvals to submit timely postmarket study data or risk losing those approvals. The requirement is part of a final guidance the agency released last week, detailing how it will consider uncertainty in making benefit-risk determinations on breakthrough device PMAs, de novo classifications and humanitarian device exemptions (HDEs). Get […]
Abbott wins FDA approval for its fourth-generation MitraClip
Abbott (NYSE:ABT) announced today that U.S. FDA has approved the MitraClip G4, the most advanced version yet of the company’s transcatheter heart valve repair device to treat mitral regurgitation. Abbott expanded the number of clip sizes to four for the MitraClip G4, including clips with a wider grasping area, in order to expand the treatment options […]
DT Medtech wins PMA nod for Hintermann H3 total ankle system
DT MedTech said yesterday that it won FDA premarket approval for its Hintermann Series H3 total ankle replacement system. The Baltimore-based company said that its H3 system is a three-piece, mobile-bearing implant that is indicated for use as a non-cemented implant intended to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or […]
FDA clears Gore’s Cardioform ASD occluder
W.L. Gore & Associates said today that it won FDA premarket approval for its Gore Cardioform ASD occluder designed for the percutaneous closure of ostium secundum atrial septal defects. Approval came supported by data from the pivotal stage of Flagstaff, Ariz.-based Gore’s ASSURED clinical study, which reported a 100% closure success rate at six months post-implant. […]
Stryker wins FDA PMA for Neuroform Atlas brain aneurysm stent system
Stryker (NYSE:SYK) said today that it won FDA premarket approval for its Neuroform Atlas stent system intended for use in treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The Neuroform Atlas stent system previously won approval from the FDA under a humanitarian device exemption which restricted its use to specific hospitals with institutional […]
Report: AI-based med devices could leave makers liable for ‘learned’ changes
A new push from the FDA for more artificial intelligence-powered devices could leave device makers liable for changes the devices ‘learn’ after their initial approval by the federal watchdog, according to a Bloomberg report. AI-powered devices ingest new data and adjust accordingly – a facet that could make them incredibly valuable in medtech, but one […]
Boston Scientific wins FDA approval for Vici peripheral venous stent
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for the Vici peripheral venous stent it acquired when it bought Veniti last year. Marlborough, Mass.-based Boston Scientific said the FDA approved Vici for treating iliofemoral venous obstructive disease. The company inked a deal worth up to $160 million last August to acquire the […]
Staar Surgical shares drop on FDA request for more data on EVO/EVO+ Visian lenses PMA bid
Staar Surgical (NSDQ:STAA) shares are down more than 10% after the company said it received a letter from the FDA’s Center for Devices and Radiological Health requesting more data for the premarket approval application supplement for its EVO/EVO+ Visian implantable collamer lenses for myopia and myopia with astigmatism. The federal watchdog said that the supplement lacked […]
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