Medical device start-up Surgical Innovation Assets said yesterday it won FDA 510(k) clearance for its DuraSorb monofilament mesh, designed for reconstructive and cosmetic surgery. The newly cleared DuraSorb mesh is the first from a line of advanced bioresorbable technologies, the Chicago-based company said. The DuraSorb is intended to integrate into the patient’s tissue to provide […]
EyePoint nabs CMS reimbursement for Dexycu cataract surgery drug
EyePoint Pharmaceuticals (NSDQ:EYPT) said this week that the Centers for Medicare and Medicaid Services approved transitional pass-through status and reimbursement of its dexamethasone intraocular suspension, Dexycu. The FDA-approved product is designed to treat inflammation following cataract surgery using a single, intraocular dose of long-acting dexamethasone. Get the full story at our sister site, Drug Delivery Business […]
FDA issues draft guidance on covering uncertainty in benefit-risk determinations
The FDA this week released draft guidance covering uncertainty in making benefit-risk determinations for certain medical devices, laying out the factors that the agency considers for such determinations. At the top of the agency’s list are considering “the extent of the probably benefits of the device, including type, magnitude, probability, duration and frequency of those […]
Baxter wins FDA nod for Actifuse Flow bone graft substitute
Baxter (NYSE:BAX) said today it won FDA clearance for its Actifuse Flow bone graft substitute, indicated for use in a variety of orthopedic surgical procedures. The Actifuse Flow graft uses proprietary silicate-substituted technology from the Deerfield, Ill.-based company’s Actifuse bone graft substitute, intended to enhance silicon levels to accelerate bone formation. The newly cleared graft requires […]
TransEnterix submits FDA clearance bid for Senhance ultrasonic instrumentation
TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission for its Senhance Ultrasonic instrument system, designed to operate with its Senhance robotic platform. The Research Triangle Park, N.C.-based company said that the approval would allow the system to utilize ultrasonic devices designed to deliver controlled energy to ligate and divide tissue and minimize thermal injury […]
Embolx wins CE Mark approval for next-gen Sniper balloon occlusion microcaths
Embolx said today it won CE Mark approval in the European Union for its Sniper Balloon occlusion microcatheters designed for pressure-directed arterial embolization therapy. The Sunnyvale, Calif.-based company said that the newly cleared Sniper Balloon catheter features improvements intended to enhance access and navigation through small complex vascular structures. The catheter is available in 110 […]
FDA: Labeling requirements to add 2m hours to medtech industry’s regulatory burden
New FDA labeling regulations submitted to the FDA’s Office of Management and Budget are expected to add an additional approximate 1.6 million hours of work to record keepers at the agency and in the industry, according to an FDA notice. The added burden comes from changes to the federal watchdog’s medical device labeling regulations, which […]
Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant
Sonova Holding AG (SIX:SOON) subsidiary Advanced Bionics said yesterday that it won FDA approval for its HiRes Ultra 3D cochlear implant. The newly approved implant is cleared for use during magnetic resonance imaging examinations as it features a new magnet design which provides alignment with an external magnetic field in any direction. The magnet allows users […]
Avinger asks for FDA approval of small-vessel PAD device
Avinger (NASDAQ:AVGR) has filed for 510(k) clearance of its Pantheris small-vessel “lumivascular” atherectomy device for treatment of peripheral artery disease (PAD). The Pantheris small vessel (SV) device extends the company’s line of Pantheris catheters, the first and only image-guided atherectomy devices for the treatment of PAD, which is estimated to affect over 12 million people in the […]
ivWatch wins CE Mark for continuous IV site monitor
ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device. The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient. Get the full story at our sister site, Drug Delivery Business News.
FDA releases Zimmer Biomet warning letter
The FDA yesterday released the warning letter it sent last week to Zimmer Biomet (NYSE:ZBH)over quality violations found during 2016 and 2018 inspections at a plant in Warsaw, Ind. Zimmer revealed its receipt of the August 24 letter earlier this week, saying it doesn’t expect to take a material hit from resolving the issues flagged in the […]
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