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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. CPETWise automates and standardises CPET workflow, transforming complex physiological data into streamlined processes. CPETWise allows clinicians to maintain oversight of the primary data and its interpretation throughout the process. Credit: SOMKID THONGDEE / Shutterstock.com. 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…
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.
Source: Medical Device Network