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NEW YORK (GenomeWeb) – The US Food and Drug Administration said today that it is altering the way it provides 510(k) clearance for medical devices, including in vitro diagnostic products, and that the new clearance pathway will rely less on older predicate products already on the market.

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Sep
16
Sponsored by
ArcherDX

This webinar will discuss a next-generation sequencing approach for detecting genomic mutations in hematologic maglignancies.

Oct
24

This webinar will tell the story of Versiti’s journey in transforming genetic testing from a manual to a digitized process. It will include detail on how the organization succeeded, pain points along the way, a novel approach to variant assessment, and future plans for the program.