Search Results for Breakthrough Device

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FDA, CMS: Second Parallel Review Decision Ever for NGS Test By Michael Mezher - Published 01 December 2017

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on Thursday announced joint approval and coverage decisions for Foundation Medicine's FoundationOne CDx next generation sequencing (NGS) based test.

Categories: News, US, FDA, In vitro diagnostics, Reimbursement, Submission and registration

Tags: Parallel Review, CMS, FoundationOne CDx, Breakthrough Device

Senators Seek to Expedite FDA Review of 'Breakthrough' Medical Devices By Alexander Gaffney, RAC - Published 27 April 2015

Medical device manufacturers may soon benefit from an expedited review pathway now only afforded to "breakthrough" pharmaceutical products if a bipartisan trio of US legislators have their way.

Categories: News, US, CDRH, Medical Devices

Tags: Breakthrough Therapy, Breakthrough Device, Breakthrough Technology, Advancing Breakthrough Devices for Patients Act, Congress, Senate, Legislation, Bill