Global Device Approvals Snapshot: 4-10 June 2019
Executive Summary
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week’s approvals include the FDA’s approval of new non-adjunctive labeling for Senseonics’ Eversense continuous glucose monitor and a de novo for Innovative Health Solutions’ IB-Stim percutaneous electrical nerve field stimulator to treat pain associated with irritable bowel syndrome.
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Continuous Glucose Monitor From Senseonics Earns FDA Approval For ‘Non-Adjunctive’ Claim
Senseonics now can promote its Eversense continuous glucose monitoring system as a replacement for fingerstick testing to help patients make diabetes treatment decisions during the day, following FDA approval of a new non-adjunctive indication.
FDA Approves The First Device To Treat Pain Caused By Irritable Bowel Syndrome
Innovative Health Solutions IB-Stim percutaneous electrical nerve field stimulator is indicated to aid the reduction of functional abdominal pain in patients ages 11 to 18 with irritable bowel syndrome when combined with other therapies.
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.