Israeli company BioControl Medical has announced U.S. FDA approval to begin the second phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-centre, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure.
Approval/Clearance
FDA Clears FSS FlexStent® Biliary Self-Expanding Stent System Range Extensions
Flexible Stenting Solutions inc., has announced receipt of FDA 510(k) clearance for an increased range of sizes of its FlexStent® Biliary Self-Expanding Stent System, including 9 and 10 mm diameters in lengths up to 100 mm.
CE Mark For MEDIHONEY® HCS Coincides With BMJ Paper Supporting Honey Application In Acute Wounds
In one of life’s pleasing little coincidences a newly published meta-review of wound care studies has, among its conclusions, established that topical honey reduces wound healing time when compared to film or gauze-based dressings for burns. Derma Sciences, Inc., with perfect timing has announced the CE Marking for its patented MEDIHONEY® HCS (hydrogel colloidal sheet) dressings, containing (you’ve guessed it), honey.
US FDA 510(k) Clearance for Integrity Life Sciences’ Integrity Spinal Care Systems
Integrity Life Sciences has somewhat belatedly announced FDA 510(k) clearance for its Integrity Spinal Care System. In a press release, issued this week, the company says it gained clearance on April 5th, 2011.
Freedom Total Knee® System Now Available In China
Maxx Medical has announced that its “Freedom Knee” has recently received Chinese SFDA approval and will shortly be available throughout the country. Freedom Knee is a complete, high-flexion primary knee replacement system specifically engineered to address the need for smaller sized and differently proportioned implants that better support Asian lifestyle and physiology.
FDA Clears r4 Vascular’s Vector™ High Pressure PTA Balloon
r4 Vascular, Inc. has announced FDA clearance to market its Vector™ Percutaneous Transluminal Angioplasty balloon catheters in 28 sizes. All Vector™ balloon catheter sizes are rated for up to 30 atmospheres of pressure and are radiopaque when deflated or inflated.
Intraoperative Nerve Monitoring In Robotic Surgery A Reality As FDA Clears ProPep Surgical’s System
FDA has cleared ProPep’s Nerve Monitoring System, the first real-time nerve monitoring system specifically designed for use during robotic surgery.
FDA Approval For Abbott’s Healon EndoCoat Protective Gel for Cataract Surgery
Abbott has announced that it has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs) with the FDA approval of Healon EndoCoat OVD, a device intended for use as a surgical aid in cataract extraction and intraocular lens (IOL) implantation.
CE Mark For TranS1 VEO™ Minimally Invasive Lateral Access Fusion System
Minimally invasive lumbar spine device company TranS1 Inc., has announced it has received CE mark approval in the European Union to market its VEO™ lateral access fusion system for interbody fusions.
Brainsway Adds Neuropathic Chronic Pain To CE Marked Indications For Its Deep TMS System
Israeli company Brainsway Ltd. has received CE Mark for its Deep TMS system to treat neuropathic chronic pain (“neuropathic pain”). This indication adds to the treatments already CE marked, which include clinical depression among others.
CE Mark For New GORE® EXCLUDER® AAA Endoprosthesis Sizing Options
W. L. Gore & Associates, Inc. has received CE mark for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the Gore® Excluder® AAA Endoprosthesis for treatment of abdominal aortic aneurysms(AAA). The company says its new diameter devices provide physicians with the ability to repair AAAs in a wider range of anatomies eligible for minimally invasive endovascular AAA repair.
FDA 510(k) Clearance For Teleflex’s ArrowADVANTAGE5 PICC
Teleflex Incorporated has announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter has received FDA 510(k) clearance for central venous pressure monitoring indication.
FDA Clearance For Synergetics USA’s VersaVIT™ Vitrectomy System
Synergetics USA, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VersaVIT™, a novel vitrectomy system for the retinal surgery market.
Flexible Stent Solutions’ Flexstent Iliac Iteration CE Marked
Flexible Stent Solutions has been granted CE mark for an extended range of its Flexstent peripheral vascular stents. The new line, called Flextent Iliac, does pretty much what it says on the tin, extending the company’s offering to cover more vessels.
FDA 510(K) For Intrinsic Medical 3D IMI Spectrum Workstation
Intrinsic Medical Imaging says its newly FDA cleared, next generation 3D capabilities will provide visualisation and quantification tools designed to improve on existing conventional 2D and 3D methods.
FDA Approves First Glaucoma Stent For Use With Cataract Surgery
One of the smaller devices featured on our pages, but nonetheless significant. Californian ophthalmic device company Glaukos has gained FDA approval for its iStent device, which relieves intraocular pressure in glaucoma patients.