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Global Device Approvals Snapshot For March 18 - March 25, 2019

Executive Summary

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.

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FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device

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.

CardioFocus' HeartLight X3 Endoscopic AFib Ablator Earns CE Mark

HeartLight X3 is the third-generation version of the HeartLight endoscopic laser ablation system for pulmonary vein isolation to treat atrial fibrillation.

Medtronic, The Foundry Invest In New Transcatheter Mitral Repair Technology

The deal gives Medtronic the exclusive right to acquire Half Moon Medical, a start-up developing a mitral valve repair system to compete with Abbott’s MitraClip.

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