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US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance

Executive Summary

The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.

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