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.
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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.
News We're Watching: GE, Biofourmis Partnership, Tricuspid Procedure Boom, Boston Scientific Borrows $2Bn, And More
Medtech Insight's News We're Watching highlights some recent business and R&D developments you may have missed. This week, GE Healthcare and Biofourmis announced a deal to collaborate on virtual care; Cleerly touts a new CPT code for its Ischemia cardiac diagnostic software; Boston Scientific announced how it plans to pay for Axonics; a Wells Fargo survey suggests the market for transcatheter tricuspid valve repair and replacement will grow faster than previously imagined; Virtual Incision earns FDA de novo authorization for its MIRA miniaturized surgical system for colectomy procedures; and MMI and Fabric announce major financing rounds.