Boston Scientific announced today that FDA has approved revised product labeling for its INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® ICDs and CRT-Ds to reflect increased longevity projections for these devices. The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings.
Reported by dotMedNews.com: FCC could open spectrum to wireless body sensors May 18, 2012 by Brendon Nafziger, DOTmed News Associate Editor Patients in intensive care units are typically festooned with a mass of monitoring wires, leads, pads and electrodes. Not only is this an infection control hazard, which some researchers estimate costs the industry billions
St. Jude today announced FDA approval of its Ellipse™ ICD. The device’s shape was designed with feedback from more than 200 physicians from around the world. The Ellipse ICD offers physicians unique design advancements, resulting in a high-energy ICD that occupies barely 30cc. According to the announcement, “The Ellipse ICD’s unique shape was conceptualized by physicians during focus groups
St. Jude Medical today announced FDA approval of its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients