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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.

One of the most significant of the latest approvals is the Japan Ministry of Health, Labour and Welfare's approval of Roche's FoundationOne CDx, a first-of-a-kind comprehensive companion diagnostic, which simultaneously...

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