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

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.

FDA approved background, 3D rendering, blue street sign

[Editors' note: For sortable and searchable tables of all 2016 US and non-US approvals and clearances, check out our Approvals Tracker.]

US FDA cleared 222 510(k)s last month. It’s a below-average amount for the US agency, but there was at least one long-awaited, potentially practice-changing advance that made it through to...

Meddevicetracker subscribers can access Roche's diagnostics pipeline and portfolio, and a profile of W.L. Gore, among other companies discussed in this month's US Approvals...

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