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Gillette Children's Hospital

This article was originally published in The Gray Sheet

Executive Summary

St. Paul, Minnesota hospital's CranioCap cranial orthosis for treatment of deformational plagiocephaly gains FDA market go-ahead. Although two orthotic specialist companies have previously received clearance for similar devices, Gillette is the first hospital to receive agency approval. The $2,000, custom-made helmet will be marketed to regional pediatricians. The device requires a prescription and a series of adjustment procedures by specialists at additional cost



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