FDAnews Device Daily Bulletin

Medical technology trade groups are pressuring the Centers for Medicare & Medicaid Services (CMS) to immediately release the nearly year-late Physician Payment Sunshine Act final rule, but want the agency to hold off on collecting data on manufacturer and group purchasing organization payments to doctors until 180 days after the rule’s debut.

The U.S. Office of Management and Budget has approved the U.S. Food and Drug Administration’s (FDA) long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency.

Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE (Conformité Européenne) Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

It’s ironic that keeping hearts beating at a steady pace represents more than half of medical device maker Medtronic’s business, given its stock price has dropped nearly 22% over the last five years.

CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced clinical results showing meaningful and sustained low clinical events for patients with ischemic heart failure three years following Percutaneous Ventricular Restoration (PVR) therapy with the first-of-its-kind catheter-based Parachute Ventricular Partitioning Device.

Advances in large-molecule biologic treatments—and the emerging shift of care from hospitals and clinics to the home—are two of the factors influencing the ever-evolving healthcare market.

St. Jude Medical, Inc., a global medical device company, today announced results of the FAME II Trial demonstrating that patients with FFR-guided stenting plus the best available medical therapy had superior outcomes to those treated with medical therapy alone.

AnSem is in the business of translating real world problems into ASIC solutions by matching up RF, analog and digital processing elements to transform real world inputs into the required outputs.