Global Device Approvals, Weekly Snapshot: June 11-17, 2018
Executive Summary
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker.
You may also be interested in...
'Sutureless' Surgical Aortic Valves Gain Medicare Bonus Payments
Edwards LifeScience’s Intuity Elite and LivaNova’s Perceval sutureless valves were granted a $6,000 new technology hospital inpatient add-on payment for fiscal 2018.
Wright Sees Potential $1B+ Market Opportunity With Newly-Approved Orthobiologic
The Augment biologic-based device was approved for use in ankle and hindfoot fusions after overcoming multiple regulatory challenges, opening up a $300 million US market opportunity. It's the first indication for a product platform that Wright hopes to extend to use in soft-tissue procedures such as rotator cuff or tennis elbow repair, which represent a $1 billion-plus opportunity.
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.