FDA lifts penalties on Boston Scientific

04/16/07 - newratings.com

NEW YORK, April 16 (newratings.com) – Medical device manufacturer Boston Scientific (BSX) Monday announced that the Food and Drug Administration (FDA) has lifted penalties imposed on the company during 2005.

The Natick, Massachusetts-based company said that the FDA has lifted the sanctions after a re-inspection of the plant during November-December 2006 and has accepted improvements in the quality-system. Boston Scientific’s Guidant unit can resume the export of pacemakers and defibrillators from its factory in St Paul, Minnesota. The resolution of these deficiencies will enable the company to win approvals for its new heart-rhythm products in the US, defibrillators and pacemakers. Several thousands of Boston Scientific’s defibrillators and pacemakers had been recalled in 2005, since the devices had a malfunction risk. Bloomberg quoted Daniel Owczarski, an analyst at Soleil-Belmont Harbor Research, as saying, "Boston Scientific can operate at full capacity, and all the development programs can go full-steam ahead."