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Global Device Approvals Snapshot: 11-17 June 2019

Executive Summary

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker, including a PMA supplement for Agilent’s PD-L1 IHC 22C3 pharmDx companion diagnostic for Merck’s Keytruda (pembrolizumab), an anti-PD-1 drug, for patients with head and neck squamous cell carcinoma. The US FDA also approved a supplement for the Cochlear Nucleus Profile Plus Series Cochlear Implant, designed to be safe with magnetic resonance imaging.

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