Bausch + Lomb has gained FDA 510(k) clearance for use in laser-assisted lens fragmentation during cataract surgery.
Regulatory
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.
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.
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.
FDA Clears Surgical Theater’s Surgical Navigation Advanced Platform
Augmented reality becomes a reality with the U.S. FDA clearance of Surgical Theater’s Surgical Navigation Advanced Platform (SNAP).
FDA Clears Itamar Medical’s WatchPAT™ Unified Sleep Apnea Diagnostic Device
Israeli device company Itamar Medical has reported the U.S. FDA clearance of its new and upgraded WatchPAT™ Unified sleep apnea diagnostic device.
Ophthalmics: CE Mark for STAAR Surgical’s Visian® ICL™ Preloaded System
IOL and Ophthalmic device company STAAR Surgical has received CE Mark approval for its new Visian® ICL™ Preloaded System.
FDA Clears Edwards Lifesciences’ Advanced Noninvasive Hemodynamic Monitoring System
The U.S. FDA has cleared Edwards’ ClearSight system, a noninvasive monitor that provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications
FDA 510(k) Approval for Encision’s AEM EndoShield™ Burn Protection System
Encision Inc., a medical device company that exists to prevent dangerous stray electrosurgical burns in minimally invasive surgery, has received FDA 510(k) clearance for its AEM Endoshield™ Burn Protection System.