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This week, Gray Sheet reporters and editors discuss CDRH's new pediatric chief medical officer, Cohera's Sylys surgical sealant, Cerebral Assessment System's Cognivue early dementia test, Xagenic's novel point-of-care molecular diagnostic platform, Comprehend's cloud-based system for managing clinical trial data, a Q&A with a legal expert about the federal court’s “20-hour" 510(k) position and Bayer’s sale of its diabetes care business to Panasonic Healthcare.