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Medical Devices / Submissions and Approvals

Baebies Wins FDA de novo Clearance for Newborn Screening Platform

Feb. 8, 2017
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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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