Current Headlines

  1. Baxter, Satellite Healthcare Partner To Improve Patient Access To Latest Dialysis Technology
    8/26/2016

    Baxter has signed a four-year agreement with Satellite Healthcare, a non-profit organization that provides kidney dialysis and other related services. Baxter’s latest technology in peritoneal dialysis, hemodialysis, and continuous renal replacement therapy will be incorporated into Satellite Healthcare’s service offerings for over 7,000 patients in the U.S.

  2. Medtronic Beats First Quarter Estimates, Optimistic On HeartWare, Mazor
    8/26/2016

    Medtronic's first quarter net income rose due to lower costs and tax payments, enough to offset a slight decrease in sales partly attributed to a down product cycle in the United States. Company executives, however, foresee a rebound in upcoming quarters as new products gain regulatory approval. Also, new acquisition HeartWare is expected to establish itself as a key performance driver going forward.

  3. Batteries Made From Melanin Could Power Ingestible Devices
    8/25/2016

    Scientists from Carnegie Mellon University (CMU) have developed a battery made from melanin, a naturally occurring compound in human skin, eyes and hair, which they say can power a 5 milliWatt device for 18 hours.

  4. FDA Finalizes Guidance On Benefit-Risk Determinations, Patient Preference Information
    8/25/2016

    The U.S. Food and Drug Administration (FDA) has issued final guidance on factors in making benefit-risk determinations for premarket approval (PMA) and de novo classifications, as well as related final guidance on patient preference information to help FDA evaluate the benefit-risk profile of certain devices.

  5. Industry, Patient Groups Seek Clarity From FDA On Sharing Patient-Specific Device Data
    8/24/2016

    Patient organizations and industry groups want the U.S. Food and Drug Administration (FDA) to clarify salient points in its draft guidance on how manufacturers should share patient-specific data with patients.

  6. FDA Clears Bio2 Medical Catheter Indicated For Use In High-PE Risk Patients
    8/24/2016

    Bio2 Medical is pleased to announce the Angel® Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA).

  7. FDA Clears Additional Lumbar Interbody Fusion Device Sizes From Amedica
    8/24/2016

    Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride as a platform for biomedical applications, is pleased to announce the U.S. Food and Drug Administration (FDA) clearance of expanded Valeo® II Lateral Lumbar sizes.

  8. FDA Clears First Computerized Cognitive Test For Concussion
    8/24/2016

    The FDA has for the first time cleared a computerized diagnostic device designed specifically to evaluate a patient’s cognitive function immediately following a head injury and a suspected traumatic brain injury (TBI), otherwise known as concussion. While the Immediate Post-Concussion Assessment and Cognitive Testing (imPACT) device cannot conclusively diagnose TBI on its own, or direct a course of treatment, the tool offers point-of-care quantitative evaluation to assist trained healthcare providers in making treatment decisions.

  9. UDI Compliance Date For Class II Devices Is Sept. 24 – 3 Tips To Meet The Deadline
    8/24/2016

    The compliance date for device labelers to place Unique Device Identifiers (UDIs) on their Class II devices is approaching quickly.

  10. J&J’s Ethicon, Touch Surgery Collaborate On Training Simulation
    8/24/2016

    Ethicon, Inc., part of the Johnson & Johnson Medical Devices Companies, announces a strategic collaboration with Touch Surgery to help improve patient outcomes by delivering simulated surgical training based on the safe and efficacious use of Ethicon products in a free mobile app that can reach medical professionals in even remote regions of the world.