The US FDA has cleared V.A.C.®Via™ Negative Pressure Wound Therapy System from Kinetic Concepts, Inc., featuring a diaphragm pump for faster draw down, longer battery life and higher leak rate threshold than its forebear.
Products
CE Mark and First Implant for Sorin’s “Removable Stent” Biological Valve
Sorin gets CE mark approval for Solo Smart,the evolution of Freedom Solo, a stentless and biological aortic valve with no synthetic material, proven outstanding hemodynamic and clinical performance.
Tensyn™ Band 510(k) For Syndesmosis Repair: Come on Dallen, Show Us Your Wares
Back in July, Dallen Medical submitted its 510(k) for the Tensyn™ band for fixation of ankle syndesmosis. Now the company is reporting that the FDA has duly cleared the product for market.
Final PMA Module Submitted for TissuGlu® Surgical Adhesive
Surgical Adhesive manufacturer Cohera Medical, Inc.® has submitted its fourth and final FDA PMA module that would ultimately see TissuGlu® indicated for reducing drainage following abdominoplasty procedures in the US.
US and EU Nods for Boston Scientific’s Direxion™ Torqueable Microcatheter
Boston Scientific’s FDA cleared and CE mark approved new embolectomy catheter features a proprietary shaft design that the company says enables better control In hard-to-navigate Vessels.
Delamination Risk Prompts FDA Class I Recall of Medtronic’s Guidewires
The US FDA has issued its highest category of of recall (Class I) for a variety of Medtronic Guidewires, due to the potential for their PTFE coating to part company with the core.
Bigging Up the World’s Smallest CPAP machine
Human Design Medical, LLC is about to release the most versatile cpap device ever. The company says its Z1™ is a new innovative cpap device that is significantly lighter, smaller, quieter and more integrated than other cpap machines and is changing the rules of design, portability and user experience in the cpap industry.
FDA Approval Brings New Treatment Option for Uncontrolled Epilepsy
Neuro implant developer, NeuroPace has announced the U.S. FDA approval of its RNS Stimulator, a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.
Newly CE Marked Tissue Damage Detector Launched at Medica
Bruin Biometrics, LLC has gained CE Mark approval to market the SEM Scanner in the European Union. The SEM Scanner is that is intended to detect localized tissue edema and pressure induced tissue damage that may lead to the formation of pressure ulcers before damage becomes visible on the skin’s surface.
CE Mark for ReliantHeart HeartAssist5® Ventricular Assist Device
The ReliantHeart HeartAssist 5®Ventricular Assist Device (VAD) has gained CE Mark approval in Europe for use in patients requiring ventricular support due to end stage heart failure. The HeartAssist 5® is approved for bridge to transplant (BTT) patients awaiting cardiac transplantation and for destination therapy (DT) patients who are not candidates for cardiac transplantation.
All Eyes on Watchman FDA Panel Meeting in December
December 11th sees the FDA’s Circulatory System Devices Panel meet to discuss, make recommendations, and vote on information related to the premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage Closure Technology.
CE Mark for Avedro’s KXL II ™ Non-Surgical Myopia Correction System
Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, has gained CE Mark clearance for its KXL II System, building on the company’s portfolio of technologies aimed at non-surgical correction of ophthalmic conditions.
Medtronic’s Software Gains FDA Nod for Use in Detecting ICD Lead Issues with Non-Medtronic Leads
Medtronic’s Lead Integrity Alert software is designed to detect implantable pacing lead failures better than impedance monitoring alone. Now the company has gained FDA approval for its system to be used in the detection of problems with other manufacturers’ leads, which opens up a further 12,000 case in the US alone.
Veniti(TM) Hopes Newly CE Marked Vici(TM) Venous Stent Will Conquer Venous Obstruction
Veniti™, Inc., has received approval to CE Mark the Veniti Vici™ Venous Stent, specifically designed for the treatment of venous obstruction. In addition, the company received CE Mark approval for their varicose vein ablation product, the Veniti Veni™ RF Plus Ablation System.
Paxeramed Debuts Industry’s First Social-media Medical Images Sharing Module
Medical imaging company Paxeramed has launched the industry’s first medical imaging sharing module to social media. The module anonymizes selected CT, MRI and X-Ray images and allows users to share it to social-media platforms from their reading workstations or dedicated viewing apps.
Platforms like Facebook and Twitter allow the shared images to be uploaded to private healthcare and hospital social media groups in a secure and HIPAA compliant manner.
CE Marking Means Gore Has Endovascular Treatment Option for Iliac Artery Aneurysms
W. L. Gore & Associates has gained CE Mark approval for its GORE EXCLUDER Iliac Branch Endoprosthesis. The company says Excluder is the first complete, fully engineered system intended for endovascular treatment of common iliac artery aneurysms or aorto-iliac aneurysms.