Global Device Approvals Snapshot For March 18 - March 25, 2019
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week FDA approved Impulse Dynamics’ Optimizer Smart impulse generator for cardiac contractility modulation therapy, CardioFocus’ HeartLight Endoscopic Ablation system earned a CE Mark, and Health Canada approved a new version of DarioHealth’s smart-phone compatible continuous glucose monitor.
You may also be interested in...
The Optimizer Smart implantable pulse generator delivers Cardiac Contractility Modulation therapy to improve the quality of life and functional status of patients with advanced heart failure who are not indicated for cardiac resynchronization therapy. The agency granted Optimizer Smart as a Breakthrough Device because of its potential to improve outcomes for heart failure patients without other options.
HeartLight X3 is the third-generation version of the HeartLight endoscopic laser ablation system for pulmonary vein isolation to treat atrial fibrillation.
New trial data shows Boston Scientific’s Sentinel cerebral embolic protection device may reduce the risk of disabling stroke, but it does not appear to reduce the overall risk of stroke.