Global Device Approvals Snapshot: 4-10 June 2019
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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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.
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.
New trial data shows Boston Scientific’s Sentinel cerebral embolic protection device may reduce the risk of disabling stroke, but it does not appear to reduce the overall risk of stroke.