Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems - Draft Guidance for Industry and FDA Staff

Asides

• Mike Hammes, former CEO at Sunrise Medical has been appointed Chairman at James Hardie.

  - #

• Recently appointed Michael Cannizzaro, vice chairman, president and CEO of Sunrise Medical has hired Pete Coburn as senior vice president of mobility sales and marketing. Coburn is recently from Cardinal Health Medical Products.

  - #

• Conor Medsystems, LLC has concluded that the COSTAR II (CObalt Chromium STent with Antiproliferative for Restenosis) trial, the pivotal study for the CoStar® cobalt chromium paclitaxel-eluting coronary stent, failed to meet its primary endpoint.

  - #

• FDA seeks comments on BGMS (essentially diabetic products using fingerstick method) Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems (BGMS) - Draft Guidance for Industry and FDA Staff

  - #

• While re-intervention rates at one year were similar between arch rivals Johnson and Johnson and Boston Scientific, this study claims that Taxus® has statistically superior performance in the fast growing diabetic population.

  Boston Scientific Corporation - TAXUS® Performance Superior to Cypher® in Diabetic Patients in Head-to-Head Study

  - #