FDAnews Device Daily Bulletin

Two Democrats on the House Energy and Commerce health subcommittee crossed the aisle to join Republicans in approving legislation to repeal the Independent Payment Advisory Board (IPAB).

A federal court has ordered New Jersey-based Accurate Set to cease operations until its restorative dental products receive FDA approval.

Varian Medical Systems issued a field safety notice for its Eclipse Treatment Planning System because machines with “virtual jaws” may give an incorrect drug dosage to patients.

A company that licensed two patents for implantable cardiac defibrillators to Boston Scientific told the Federal Circuit that a district court wrongly found Medtronic did not infringe either patent, saying it was Medtronic’s job to prove it wasn’t violating the patents.

The medical device industry wants the Union Government [India] to frame policies and regulations that will encourage manufacturers.

Karen Sandler was 31 years old, working at a non-profit organization providing free legal help to computer programmers, when she was diagnosed with an enlarged heart and informed that she’d need a machine to help keep her alive.

Abbott announced that the FDA approved the Absolute Pro Vascular Self-Expanding Stent System for the treatment of iliac artery disease, a form of peripheral artery disease that affects the lower extremities.

Edwards Lifesciences reported that on March 3, 2012, the company filed its official response to the Centers for Medicare & Medicaid Services on its Proposed National Coverage Determination for Transcatheter Aortic Valve Replacement.

Zimmer Holdings announced layoffs at its Warsaw, Ind., headquarters, pointing to the expected burden of the medical device tax as partly responsible for some of the losses.