Covidien has announced FDA 510(k) clearance to market its Covidien Nellcor™ Bedside SpO2 Patient Monitoring System.
FDA Approval
510(k) Clearance For Medtronic’s Orthopaedic Bipolar Sealer with Cutting
Medtronic, Inc. has announced the FDA 510(k) clearance for its Aquamantys®3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business. Combining sealing with cutting in a single device should make procedures more efficient, according to the company.
Milestone Alert! First FDA Cleared Robot-Assisted PCI System
Vascular robotics company Corindus Vascular Robotics, has announced FDA 510(k) clearance has been granted for its CorPath 200 System to be used in percutaneous coronary interventions (PCI).
FDA Clearance For Siemens’ MAGNETOM Spectra 3T MRI System
Siemens Healthcare has announced that its MAGNETOM Spectra 3 Tesla MRI system has received US FDA clearance. The company believes it has achieved the optimal blend of reduced ownership costs, excellent image quality and rapid scan times with this system which it says provides hospitals and radiological institutes with easier access to 3T technology.
FDA Clears First Ever Bi-directionally Retrievable Vena Cava Filter From Crux Biomedical
Crux Biomedical has announced FDA clearance for its novel Vena Cava Filter which uniquely features bi-directional retrieval via either the femoral or jugular vein access.
FDA Clears Expanded Size Range Of TriReme’s Glider™ PTCA Balloon Catheter
TriReme Medical, Inc. has announced that it has received FDA clearance for an expanded matrix of sizes for its unique Glider PTCA balloon catheter. Glider is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 3.5mm and in lengths from 4mm to 20mm.
FDA 510(k) Clearance For Olea Sphere Medical Imaging Software
Imaging specialist Olea Medical, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US.
FDA Clears Kimberly Clark’s Kimguard One-Step Sterilisation Wrap Portfolio With One-Year Package Integrity
Kimberly-Clark Health Care has announced that it has received FDA 510(k) clearance for its KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity for KC300 to KC600 for Pre-vacuum Steam and Ethylene Oxide.
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.
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.
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.
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.
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.