FDA Grants 510(k) Clearance to Medibyt for CPETWise Software

FDA grants 510(k) clearance to Medibyt’s CPETWise solution

Israeli digital health company Medibyt has received 510(k) clearance from the US FDA for its CPETWise solution, which assists with the analysis and interpretation of CPET. The post FDA grants 510(k) clearance to Medibyt’s CPETWise solution appeared first on Hospital Management.

FDA Grants 510(k) Clearance to Medibyt for CPETWise Software

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Medibyt for its CPETWise software, a digital tool designed to assist in the analysis and interpretation of cardiopulmonary exercise testing (CPET). This regulatory approval authorizes the Herzliya-based company to begin commercializing the platform within the United States. Medibyt intends to utilize this clearance to support several ongoing corporate initiatives, includ…