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Global Device Approvals Snapshot: 25 June-1 July 2019

 
• By Reed Miller

A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. The week of 25 June to 1 July was another slow one for approvals, with no new PMAs, panel-track PMA supplements, or de novos. Japan’s MHLW approved Foundation Medicine’s companion diagnostic for Roche’s cancer drug Rozlytrek.

Approved

The US Food and Drug Administration did not approve any original PMAs or panel-track PMA supplements during the week of 25 June to 1 July.

The FDA approved 15 non-panel track PMA supplements and cleared 52 510(k)s during the last week.

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