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RegulationSeptember 2, 2026

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

Medibyt, an Israeli digital health company, received FDA 510(k) clearance for CPETWise, a software solution designed to assist in the analysis and interpretation of cardiopulmonary exercise testing (CPET). The clearance enables the company to market the tool in the US.

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