Regulatory News

  1. FDA Clears Intuitive Surgical's Ion Endoluminal System 2/19/2019

    Intuitive Surgical, Inc. (Nasdaq: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food and Drug Administration (FDA) cleared the Ion™ endoluminal system to enable minimally invasive biopsy in the peripheral lung.

  2. Medtronic's Personalized Closed Loop Insulin Pump System Earns FDA Breakthrough Designation 2/19/2019

    Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Personalized Closed Loop (PCL) insulin pump system, currently in development. The PCL technology is designed to automate insulin delivery in a way that is real-time, personalized and adapts to the user.

  3. NuVasive Gains FDA Clearance, CE Mark For Its All-Internal Precice Bone Transport System 2/19/2019

    NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) – as well as European CE mark approval – for use of its Precice® Bone Transport System, the only all-internal system of its kind on the market indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection.

  4. FDA Clears Fresenius Kabi's Fenwal Amicus Red Blood Cell Exchange System 2/15/2019

    Fresenius Kabi recently announced it has received 510(k) clearance from the U.S. Food and Drug Administration for the Fenwal Amicus Red Blood Cell Exchange (RBCx) system.

  5. FDA Clears Zimmer Biomet's ROSA One Brain Application 2/11/2019

    Zimmer Biomet has received U.S. Food and Drug Administration (FDA) clearance for the ROSA One Brain Application, a robotic surgical navigation and positioning system for use in neurosurgical procedures.

  6. Philips Launches Ultrasound System For General Imaging, Ob/Gyn 2/7/2019

    Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of the EPIQ Elite ultrasound system, a new premium ultrasound that combines the latest advances in transducer innovation and enhanced performance to improve clinical confidence and the patient experience.

  7. FDA Grants Breakthrough Designation To Cognoa's Autism Diagnostic And Digital Therapeutic Devices 2/6/2019

    Cognoa, a company at the forefront of digital behavioral health for children, today announces it has received Breakthrough Device designations from the U.S.

  8. FDA Approves Software Upgrade For Flowonix Pump Systems 2/5/2019

    Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Flowonix Maestro™ Software for Clinician Programmers used to program Prometra® Pump Systems.

  9. FDA Clears Zimmer Biomet's ROSA Knee System For Robotically-Assisted Surgeries 1/25/2019

    Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries.

  10. FDA Grants IDE Approval To CorMatrix's Cardiac Valve 1/24/2019

    CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cor™ TRICUSPID ECM® cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease.