Regulatory News
-
Medtronic Guardian Connect CGM System Approved By FDA
3/12/2018
Medtronic plc (NYSE:MDT), the global leader in medical technology, services and solutions, today announced it received U.S. Food and Drug Administration (FDA) approval for its Guardian(TM) Connect continuous glucose monitoring (CGM) system, for people with diabetes ages 14 to 75 years.
-
FDA Approves Abbott’s 15-mm Heart Valve, The World’s Smallest Commercially Available Mechanical Valve
3/6/2018
The U.S. Food and Drug Administration recently expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects.
-
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.
-
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).
-
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.
-
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.
-
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.
-
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.
-
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).
-
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.