By: IPP Bureau
Last updated : September 04, 2026 8:42 am
The company plans to expand the commercial availability of CPETWise beyond the US and explore applications in spirometry, BodyBox pulmonary function testing and sports medicine
Israeli digital health company Medibyt has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CPETWise solution, which assists clinicians in the analysis and interpretation of cardiopulmonary exercise tests (CPET).
The clearance, granted under 510(k) file K260242, enables Medibyt to proceed with the commercialisation of CPETWise in the US.
The platform is designed to automate and standardise CPET workflows, converting complex physiological data into streamlined clinical processes while allowing clinicians to retain oversight of both the underlying data and its interpretation.
“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,” said Or Inbar, CEO and co-founder, Medibyt.
“Our goal is to make advanced cardiopulmonary diagnostics more accessible, scalable, and practical for everyday clinical use,” he added.
Medibyt 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. The company has also reported growing interest from international CPET device manufacturers, potentially paving the way for additional commercial partnerships.
Prior to the FDA clearance, Medibyt completed a 100-case proof-of-concept study at the University of Washington, which 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 institutions including Columbia University, Ichilov Medical Center, Sheba Medical Center, UCLA and the University of Washington, among others.
Medibyt is continuing to develop machine-learning capabilities for the platform and has access to approximately 4,000 retrospective CPET records for ongoing algorithm development and validation.