Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Medtronic’s Physio-Control wins 510(k) for LifeNet 5.0 data network
Medtronic Inc. (NYSE:MDT) subsidiary Physio-Control Inc. announced today it has received 510(k) clearance from the Food & Drug Administration to market LifeNet System 5.0 within the U.S. LifeNet 5.0 is the latest version of Physio-Control’s web-based data network, providing emergency medical services and hospital care teams with a suite of innovative new tools and capabilities to help improve patient outcomes, trim operational costs, and streamline equipment management.
- Cook Medical wins 510(k) for Evolution fully covered esophagus stent
Cook Medical’s controlled-release esophageal stent fully covered in silicone has received 510(k) clearance from the Food & Drug Administration. The Evolution controlled release esophageal fully covered stent is designed to improve quality of life for patients with malignant esophageal strictures and tracheoesophageal fistulas by improving the patients’ ability to swallow.
- HepaLife Technologies Announces 510(k) Submission to the FDA for Its Silver Based Antimicrobial Wound Dressing
HepaLife Technologies, Inc. (OTC:HPLF) announced a 510(k) submission to the FDA by its AquaMed Technologies Inc. subsidiary seeking pre-market clearance for its silver based antimicrobial wound dressing.
- Flexible Stenting Solutions to seek Japanese approval for stents
Flexible Stenting Solutions Inc. announced the signing of an exclusive agreement with Goodman Co. Ltd. Per the terms of the agreement, Goodman will be responsible for overseeing the regulatory and clinical process in Japan. Ultimately, Goodman will seek Shonin approval from the Japanese Ministry of Health, Labor and Welfare as a pre-requisite to their marketing and distributing the FlexStent femoropopliteal and biliary self-expanding stent systems in Japan.
- Si-Bone wins CE Mark for iFuse implant
Si-Bone Inc. announced that it has received a CE Mark from the European Union for its iFuse implant system for the sacroiliac joint.
- Titan Spine wins clearance for Endoskeleton PLIF line
Titan Spine announced that it has received Food & Drug Administration clearance for its Endoskeleton TO system, a line of interbody devices placed through a posterior lumbar interbody fusion approach. The company plans to commercially release the product beginning in December, 2010.
- Avedro’s KXL System Receives the European CE Mark for Corneal Collagen Cross-Linking
Avedro Inc. announced that its KXL System for performing accelerated corneal cross-linking received the European Union’s CE Mark.
- Saadat, Masimo land European CE Mark for Aria patient monitor
Saadat and Masimo (NSDQ:MASI) jointly announced CE Mark certification and the European launch of the Saadat Aria — the first portable patient monitor with Masimo rainbow SET Pulse CO-Oximetry technology for noninvasive physiological measurements.
- Neogen’s rapid test for Salmonella enteritidis receives AOAC approval
Neogen Corp. (NSDQ:NEOG) announced that its rapid test for Salmonella enteritidis received approval from AOAC International.