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Medical Devices / Submissions and Approvals

Baebies Wins FDA de novo Clearance for Newborn Screening Platform

Feb. 8, 2017

Durham, North Carolina–based, Baebies has received de novo clearance from FDA for Seeker, which is a screening platform for newborn babies.

The assay measures for potential insufficient lysosomal enzymes from newborn dried blood spot specimens. — Cynthia Jessup

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