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Medibyt Receives FDA 510(k) Clearance for CPETWise

Shots: The US FDA has granted 510(k) clearance to CPETWise (K260242) designed to streamline cardiopulmonary exercise testing (CPET) analysis, interpretation and reporting through a standardized clinical workflow The clearance follows a 100-case proof-of-concept study at the University of Washington, where CPETWise achieved an average user satisfaction score of 4.5/5 & cut interpretation time by more…

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