Regulatory News

  1. Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark

    Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, recently announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery.

  2. Arterys’ Oncology Imaging Suite With Deep Learning Cleared By FDA

    Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, recently announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA).

  3. Embrace Becomes First FDA-Cleared Seizure-Monitoring Smart Watch

    Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.

  4. Centric Medical’s Foot and Ankle Plating System Earns FDA Clearance

    Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology announced recently the FDA 510(k) clearance of the new Foot and Ankle Plating System.

  5. FDA Clears Mevion’s Proton Therapy System

    Mevion Medical Systems has received FDA 510(k) clearance for the MEVION S250i Proton Therapy System® including HYPERSCAN pencil beam scanning (PBS) technology. 

  6. FDA Clears Zimmer Biomet’s Total Shoulder Arthroplasty System

    Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation.

  7. K2M’s 3D-Printed Expandable Corpectomy Cage With Cervical Spine Indications Gains CE Mark

    K2M Group Holdings, Inc.(NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™, and the successful completion of its first surgical case.

  8. First Wire-Free Radar Breast Tumor Localization System For Long-Term Implant Cleared By FDA

    Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term implant. The SAVI SCOUT reflector is an integral part of the SCOUT system for wire-free breast tumor localization.

  9. CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark

    CardioFocus, Inc. today announced the European CE Mark approval of the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF).

  10. Acutus Medical’s Real-Time Cardiac Mapping Systems Cleared By FDA

    Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed.