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APPROVALS ANALYSIS: Big Year For PMAs, But Slower Year For Approvals Overall

This article was originally published in Clinica

Executive Summary

Despite a record year for PMAs approved by the US FDA, total approvals globally - including FDA 510(k)s, CE marks, and approvals outside the US or Europe – were down in 2015 versus 2014, Clinica’s medtech approvals tracker shows.

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