Global Device Approvals, Weekly Snapshot: Aug. 13-19, 2018
A snapshot of global medical device and diagnostics approvals recorded during the past week in Medtech Insight's Approvals Tracker. This week, two Health Canada approvals, and more.
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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.
US FDA used its de novo review pathway to approve Brainsway Ltd.’s Brainsway Deep Transcranial Magnetic Stimulation System to treat obsessive compulsive disorder.
Medtronic says that most of the clinical trials it is sponsoring are paused due to the pandemic, which means the completion of its PMA application for the Symplicity Spyral renal denervation system will be delayed.