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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.

J&J Has Big Plans For Robotic Surgery In 2020

The company’s leadership discussed its recent investments in robotic surgery technology during Johnson & Johnson’s 2019 fourth-quarter earnings call on 22 January. The company will provide more information on its robotic surgery platforms at its investors meeting in May in New York.

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