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In Brief: Fusion Medical Technologies

This article was originally published in The Gray Sheet

Executive Summary

Fusion Medical Technologies: Receives 510(k) clearance from FDA for its RapiSeal collagen-based resorbable patch for treating air leaks that occur during pulmonary surgery. The 510(k), submitted in April ("The Gray Sheet" May 13, p. 13), included clinical data from a 26-patient, multicenter trial. The trial showed that RapiSeal was 96% effective for sealing air leaks untreatable with staples or sutures, Fusion says...



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