Regulatory News

  1. Edwards' Self-Expanding Transcatheter Heart Valve Receives CE Mark
    2/15/2018

    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
    2/15/2018

    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
    2/5/2018

    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. FDA Clears Zimmer Biomet’s Total Shoulder Arthroplasty System
    1/3/2018

    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.

  5. K2M’s 3D-Printed Expandable Corpectomy Cage With Cervical Spine Indications Gains CE Mark
    12/20/2017

    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.

  6. First Wire-Free Radar Breast Tumor Localization System For Long-Term Implant Cleared By FDA
    11/13/2017

    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.

  7. CardioFocus’ HeartLight Excalibur Balloon For AF Treatment Earns CE Mark
    10/27/2017

    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).

  8. Acutus Medical’s Real-Time Cardiac Mapping Systems Cleared By FDA
    10/24/2017

    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.

  9. FDA Clears Game Ready’s Multi-Modality Recovery Device
    10/6/2017

    The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elite™.

  10. FDA Approves Implantable To Treat Central Sleep Apnea
    10/6/2017

    The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea.