Global Device Approvals Snapshot: 30 April-6 May 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 Vici Venous iliac vein stent system and SentreHEART announced it has received a CE mark for the 50mm version of the Lariat-RS system for left atrial appendage exclusion in patients with atrial fibrillation.
You may also be interested in...
AtriCure Adds Lariat LAA Closure System With $300M SentreHeart Acquisition
AtriCure Inc. has closed a $300m structured deal to acquire SentreHEART Inc., a privately held developer of percutaneous left atrial appendage management solutions.
FDA Approves Boston Scientific’s Vici Venous Iliac Stent
The US FDA approval of Boston Scientific's Vici venous stent is based on VIRTUS trial results which met the prespecified performance goal for primary patency after one year.
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.