Covidien plc (NYSE:COV) won 510(k) clearance for a new "small jaw" cutting and sealing surgical instrument.
The clearance adds another device to the Mansfield, Mass.-based medical products maker’s 12-year-old LigaSure line of surgical tools.
The new LigaSure curved, small jaw, open sealer/divider surgical instrument is indicated for general surgery and "provides an integrated cutting mechanism independent of sealing, leaving the critical cutting decisions in the hands of the surgeon," according to the company. It is also designed for confined spaces and provides blunt dissection with a low-temperature profile and minimal thermal spread for tissue surrounding the site of the operation.
The device will be available in the United States in the first quarter of 2011, according to the company.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
- Toshiba wins FDA clearance of Auto-IMT ultrasound software
For physicians, the ability to streamline exams for determining a patient’s risk for cardiovascular disease is important in determining the patient’s clinical pathway. To enhance diagnostic efficiency, Toshiba America Medical Systems Inc. has introduced Auto-IMT, an ultrasound software tool that can measure the thickness of the intima-media layers of the carotid artery, for evaluating an asymptomatic patient’s risk of developing cardiovascular disease. The Tustin, Calif.-based unit of Toshiba Corp. (TYO:6502) recently received FDA clearance for Auto-IMT, and it is now available on the AplioTM XG, Aplio MX and XarioTM XG ultrasound systems. Toshiba’s Auto-IMT can determine the thickness of the near and far arterial walls from three segments of the carotid artery: at an optimal angle of incidence and two complementary planes.
Read more - Nuclear Regulatory Commission approves radioactive materials license for Positron Corp. facility
Positron Corp. (OTC:POSC) a molecular imaging company focused on nuclear cardiology, announced that the Nuclear Regulatory Commission (NRC) approved an amendment to their existing Indiana license for handling radioactive materials to include Positron’s Crown Point, Indiana facility.
Read more - Bacterin International announces launch of OsteoSponge SC at American Academy of Orthopedic Surgeons annual meeting
Bacterin International Holdings Inc. (OTC:BIHI), a developer of bone graft material, launched its OsteoSponge SC product at the American Academy of Orthopedic Surgeons (AAOS) 2011 Annual Meeting taking place Feb. 15-19 in San Diego, Calif. Based on favorable preclinical data, Bacterin has received permission from the FDA to market OsteoSponge SC as a subchondral bone void filler. OsteoSponge SC has demonstrated extraordinary re-generative properties in both preclinical and clinical data and, as a result, Bacterin will be presenting three separate case studies this week at AAOS.
Read more - Japan regulators grant premium reimbursement pricing to Biomet’s E1 hip bearing
Biomet Inc., a manufacturer of orthopedic and biotechnology products, announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) granted premium reimbursement pricing for the Company’s E1 Antioxidant Infused Technology hip bearing. Japan’s National Insurance listed the E1 technology on Nov. 1, 2010. The E1 hip bearing is the only technology of its type available in Japan that utilizes antioxidants to stabilize the bearing material. Biomet’s E1 Antioxidant Infused Technology prevents oxidative degradation, and, in laboratory testing, the E1 bearings demonstrated a 95 percent to 99 percent reduction in wear compared to gamma sterilized polyethylene.
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