Israeli digital health company Medibyt has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CPETWise solution, which assists with the analysis and interpretation of cardiopulmonary exercise tests (CPET).

Under file K260242, the clearance allows the company to move forward with commercialisation of CPETWise in the US.

The solution is designed to automate and standardise the workflow for CPET, transforming complex physiological data into streamlined clinical processes.