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 than 50%
- Medibyt has begun a commercial pilot with a US CPET company & is developing next-generation machine-learning capabilities. The company plans to expand internationally & into spirometry, BodyBox testing, sports medicine & performance markets
Ref: PRnewswire | Image: Medibyt | Press Release
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