Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
- Mobisante wins 510(k) clearance for smartphone ultrasound
Mobisante Inc. received 510(k) clearance from the Food & Drug Administration for its its smartphone-based ultrasound system, MobiUS. The Redmond, Wash.-based mobile health start-up startup, which began work on the device in 2007, will now begin commercializing the device, according to Xconomy Seattle. The system will cost between $7,000 to $8,000 for the whole package, which includes a Toshiba TG01 Windows Mobile phone, ultrasound probe and Mobisante’s proprietary software, CEO Sailesh Chutani told Xconomy.
- Cyberonics wins FDA approval of Aspire high capacity generator for VNS therapy
Cyberonics Inc. (NSDQ:CYBX) announced that the AspireHC (High Capacity) generator for use in vagus nerve stimulation (VNS) therapy was approved by the FDA. The AspireHC generator (development name NXT HC) represents the fifth generation of VNS Therapy technology. This product incorporates greater functionality for the benefit of patients and their physicians, including longer battery life, improved electronics and simplified features for programming. The AspireHC generator is expected to be in limited commercial release in the United States in the Company’s current quarter ending April 29, 2011. The company has also applied for the CE Mark.
- FSS lands Investigational Device Exemption approval for its FlexStent system
Flexible Stenting Solutions Inc., a leading developer of next generation peripheral arterial, venous, neurovascular and biliary stents, announced that it received full FDA Investigational Device Exemption (IDE) approval for its FlexStent Femoropopliteal Self Expanding Stent System. With this approval, FSS is authorized to begin full enrollment for the OPEN Trial (US Evaluation of Safety and Efficacy of the FlexStent Femoro-pOPliteal Self-Expanding StENt System).
- CardioGenics to file for 510(k) clearance with the FDA by Q4 2011
CardioGenics Holdings Inc. (OTC:CGNH) announced final plans for testing of its QL Care (QLCA) Analyzer. The data that will be collected from the testing at 4 hospitals in North America will be used as a key component of the Company’s 510(k) application with the FDA. The 510(k) application will allow the FDA to determine whether the QLCA is equivalent to another device that is currently approved by the FDA for commercialization. Upon approval of the application, CardioGenics will begin marketing the QLCA throughout the United States.
- Mederi Therapeutics receives 510(k) clearance for the MDRF1 radiofrequency generator
Mederi Therapeutics Inc. announced that it received FDA 510(k) clearance for its new MDRF1 Generator. The Mederi RF Generator powers the Stretta System for treatment of Gastroesophageal Reflux Disease (GERD) as well as the Secca System for Bowel Incontinence or Bowel Control Disorder (BCD).