Global Device Approvals Snapshot: April 23-29, 2019
Executive Summary
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week, the US FDA approved Boston Scientific’s Lotus Edge transcatheter aortic valve and Xvivo Perfusion’s XPS perfusate with Steen Solution.
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Boston Scientific Becomes Third US TAVR Competitor With Lotus Edge Approval
The US FDA approved Boston Scientific's Lotus Edge transcatheter aortic valve for patients who would be at high risk with surgical valve replacement. Unlike competing TAVR systems from Medtronic and Edwards, Lotus Edge can be repositioned or recaptured after it has been deployed.
Acutus Is Trying To Fundamentally Change Understanding Of Arrhythmia With AcQMap
New trial results show Acutus Medical's AcQMap platform has the ability to classify conduction patterns and localized non-pulmonary-vein therapeutic targets for ablation to treat atrial fibrillation, which could have implications for both treatment of atrial fibrillation and understanding the genetic markers for this common arrhythmia, according to the authors.
News We’re Watching: FDA Approves Medtronic's Affera, Roche's CGM Moves Closer To Approval, And More
Medtech Insight's News We're Watching covers medtech industry and research news you may have missed. This week, the Advanced Technologies and Treatments for Diabetes (ATTD) conference in Florence, Italy, included new results from studies of Roche's continuous glucose monitor and Medtronic's 780G insulin pump, Medtronic moved closer to earning FDA approval for its Affera ablation mapping and ablation system, and Linus Health expanded its technology for finding signs of cognitive problems in speech data.