CorMatrix Cardiovascular has extended the application of its CorMatrix® ECM® having received U.S. FDA clearance to market the material for Vascular Repair.
Products
FDA 510(k) Clearance for VICTUS® Femtosecond Laser use in Lens Fragmentation
Bausch + Lomb has gained FDA 510(k) clearance for use in laser-assisted lens fragmentation during cataract surgery.
Covidien Targets Accurate Liver Tumor Ablation with Emprint™ System
Covidien plc has unveiled an advanced ablation system that offers physicians predictable results regardless of the target location or tissue type.
Boston Scientific Plugs TAVI Gap with CE Mark for 25 mm Lotus™
Boston Scientific’s Lotus™ TAVI System has been enhanced by the addition of a 25mm variant to its CE marked portfolio.
CE Mark for Boston Scientific’s Ranger™ Drug-Coated Balloon
Boston Scientific Corporation has received CE Mark for the Ranger™ Paclitaxel-Coated PTA Balloon Catheter which is now to be fully launched in Europe.
FDA Clears Titan Spine’s Endoskeleton® TL Device for Lateral Spinal Fusion
Titan Spine’s newly cleared Endoskeleton® TL system utilizes a lateral approach and represents the first lateral fusion device to features the company’s implant surface technology.
New IDE Study: Will Vici Stent Conquer Venous Stent Market?
The U.S. FDA has given the go ahead to Veniti’s Vici Venous Stent system which the company says is the first to be designed specifically for venous use.
Mitek Unveils Foray into Biotherapy with Hyaluronan Injection
Sports Med device maker Mitek’s gone all biotherapy on us with its newly announced launch of MONOVISC® High Molecular Weight Hyaluronan and the PEAK™ Platelet Rich Plasma (PRP) System
Problem Solved, Cook Reintroduces Evolution® RL Lead Extraction Devices
Cook Medical is to recommence distribution in the United States of its Evolution® RL and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Sets following a two month suspension.
Single Laser Platform for Glaucoma, Retina and Cataract Treatments
French ophthalmic device company Quantel Medical has gained U.S. FDA 510(k) clearance for its Optimis Fusion™ integrated laser platform.
Pain Management Company Zynex Pained by FDA’s Warning Letter
Zynex Medical doesn’t escape the sharp edge of the FDA’s tongue in a damning letter following January audit.
Covidien Launches Enhanced Trellis Clot-Busting System
Covidien’s Trellis Peripheral infusion system features enhanced drug delivery and better clot removal.
FDA Clears Dallen’s Disposable Compressyn™ Staple Delivery System for Small Bone Fixation
Dallen Medical has gained FDA 510(k) clearance for its Disposable Compressyn™ Staple Delivery System for Small Bone Fixation
FDA Class I Recall for Medtronic Duet External Drainage and Monitoring System
The Medtronic Duet External Drainage and Monitoring System is now the subject of a Class I recall because of concerns that tubing may separate, with serious consequences for patients.
EU Launch for KCI Cellutome™ Skin Graft Harvester
Kinetic Concepts, Inc. has announced the EU launch of its CelluTome™ Epidermal Harvesting System, delivering an automated, precise and reproducible process of harvesting autologous epidermal tissue for grafting.
Terason Launches uSmart® 3300 Ultrasound System
The new Terason uSmart 3300 Ultrasound System is a portable ultrasound system that fuses Smart Technology and Smart Resolution Imaging for shared service, hospital and outpatient sectors of point-of-care ultrasound.