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.
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The solution is designed to automate and standardise the workflow for CPET, transforming complex physiological data into streamlined clinical processes.
The platform allows clinicians to maintain oversight of both the primary data and its interpretation throughout the process.
Medibyt CEO and co-founder Or Inbar said: “Receiving FDA clearance for CPETWise is a transformative milestone for Medibyt. It validates the significant work our team has completed and enables us to move forward with commercialisation in the US.
“Our goal is to make advanced cardiopulmonary diagnostics more accessible, scalable, and practical for everyday clinical use.”
The company is currently working on a commercial pilot with an unnamed leading CPET provider in the US to integrate CPETWise into existing systems and facilitate data transfer.
Medibyt has also reported growing interest from international CPET device manufacturers, which the company suggests may support further commercial partnerships.
Before FDA clearance, Medibyt completed a proof-of-concept study at the University of Washington.
The 100-case study reported an average user satisfaction score of 4.5 out of 5 and a reduction of more than 50% in the time required for CPET interpretation.
Demonstrations of CPETWise are underway at a number of institutions, including Columbia University, Ichilov Medical Center, Sheba Medical Center, UCLA, the University of Washington, and other centres.
Medibyt continues to develop new machine-learning functions, and reports access to around 4,000 retrospective CPET records for ongoing algorithm development and validation.
The company also intends to expand the commercial availability of the platform beyond the US and to explore applications in spirometry, BodyBox pulmonary function testing, and sports medicine.
