Medibyt Gets FDA Clearance for CPETWise Cardiopulmonary Test Software

Medibyt announced in a press release that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance to CPETWise, its cardiopulmonary exercise test analysis and reporting software. The clearance covers CPETWise under K260242 and allows Medibyt to begin commercialization in the United States.

CPETWise is designed to convert physiological test data into a standardized clinical workflow for CPET analysis, interpretation, and reporting. The company said the software keeps underlying data and interpretation visible to clinicians.

Medibyt said it has started a commercial pilot with a U.S. CPET company to integrate CPETWise with its systems and improve data transfer. The company also reported results from a 100 case proof of concept study at the University of Washington, including an average user satisfaction score of 4.5 out of 5 and a reduction of more than 50% in CPET interpretation time.

Demonstration environments for CPETWise are deployed at Columbia University, the University of Washington, UCLA, Sheba Medical Center, Ichilov Medical Center, and other centers. Medibyt said it is also developing machine learning capabilities using about 4,000 retrospective CPET records interpreted by CPET experts.