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Global Device Approvals, Weekly Snapshot: FoundationOne CDx In Japan

 
• By David Filmore and Reed Miller

A snapshot of global medical device approvals captured during the past two weeks by Medtech Insight's Approvals Tracker. Among the noteworthy approvals in the closing days of 2018, Roche/Foundation Medicine captured Japanese approval for its comprehensive companion diagnostic.

Approved

The last two weeks of 2018 saw 14 novel device or indication approvals in regions around the world, including noteworthy companion diagnostic decisions in Asia, and several important diagnostic or assessment tools granted go-aheads in the US.

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More from Policy & Regulation

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South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
• By Elizabeth Orr

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Switzerland Investigates Private Sector Assessment of FDA-Approved Medical Devices

 
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