Current Headlines

  1. Fast, High Definition, Low Dose: GE Healthcare Announces FDA Clearance Of Revolution CT

    GE Healthcare, a unit of General Electric Company, recently announced U.S. FDA 510(k) clearance of its Revolution CT^, which will enable physicians to diagnose even the most challenging patients. 

  2. Researchers Regenerate A Living Organ For The First Time

    A team of scientists at the University of Edinburgh, in Scotland, successfully regenerated a living organ for the very first time — an accomplishment that could prove groundbreaking in the field of tissue regeneration.

  3. Powering Medical Devices With Heartbeats And Breathing Lungs

    An interdisciplinary group of researchers from Northwestern University, the University of Illinois at Urbana-Champaign, and the University of Arizona have developed a flexible medical device capable of capturing enough electrical power from the natural motions of a beating heart or a breathing lung to power pacemakers, defibrillators, and heart-rate monitors.

  4. Reverse Medical Corporation Announces FDA IDE Approval For The BARREL Vascular Reconstruction Device For The Treatment Of Intracranial Bifurcation Aneurysms

    Reverse Medical Corporation recently announced FDA IDE approval for clinical investigation of their BARREL Vascular Reconstruction Device (VRD). 

  5. Boston Scientific Announces FDA Approval Of Innovative New Defibrillators And Heart Failure Devices

    Boston Scientific Corporation (NYSE: BSX) has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care.

  6. Intelligent Prosthetic Liners Could Ease Pain For Lower Limb Amputees

    A new device could help to relieve the pain and discomfort experienced by thousands of amputees as a result of poorly fitting replacement lower limbs. 

  7. Integrating Consumer Wearable Health Devices Will Drive Healthcare Big Data Adoption

    ​This year close to 42 million wearable wireless sports, fitness and wellness devices will ship worldwide.

  8. GSK Receives US Approval For Once-Weekly Type 2 Diabetes Treatment, Tanzeum (Albiglutide)

    GlaxoSmithKline plc recently announced that the US Food and Drug Administration (FDA) has approved Tanzeum (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. 

  9. Stryker Completes Acquisition Of Berchtold Holding AG

    Stryker Corporation announced recently the completion of its previously announced acquisition of Berchtold Holding AG (Berchtold), a provider of customer-centric healthcare equipment for over 90 years.

  10. FDA Issues New Guidance On Communication During Device Reviews

    The U.S. FDA recently released guidelines to help clarify the types of communication the agency will use during the review process for medical devices. Those guidelines specifically address the submission of premarket applications (PMAs), biologic license applications (BLAs), 510(k) premarket notifications, and other supplementary material.