US Approvals Analysis: Molecular Dx Innovations Make Waves In November
Four novel molecular diagnostics, including two next-generation sequencing platforms, gained FDA approval in November, almost half of the nine novel-device approvals last month. The agency was also active with PMA supplement approvals and 510(k) clearances during the period.
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FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.
FDA used its de novo pathway to clear Innovative Health Solution's NSS-2 Bridge – the first device for use in helping to reduce the symptoms of opioid withdrawal – as a class II device.
The agency authorized a next-generation sequencing tumor profiling system that leverages the New York State Department of Health to speed future clearances.