Medibyt Receives FDA Clearance for CPETWise Software
HERZLIYA, Israel — Medibyt, a digital health company specializing in transforming cardiopulmonary diagnostics through intelligent automation, has announced that it has received FDA 510(k) clearance for its CPETWise software. This milestone paves the way for the company’s entry into the U.S. commercial market.
CPETWise is a software solution designed to simplify the process of cardiopulmonary exercise testing (CPET) by converting complex physiological data into a standardized clinical workflow. It retains clinician visibility into the underlying data and interpretation, ensuring that medical professionals can make informed decisions based on the latest technology.
"Receiving FDA clearance for CPETWise is a significant achievement for Medibyt," said Or Inbar, CEO and Co-Founder of Medibyt. "This clearance validates our efforts and enables us to expand our commercial presence in the United States. Our goal is to make advanced cardiopulmonary diagnostics more accessible and practical for everyday clinical use."
The approval comes at a time of strong commercial and strategic momentum for Medibyt. The company is currently piloting CPETWise with a leading U.S. CPET company, aiming to integrate the software into existing systems and streamline data transfer. Additionally, Medibyt has attracted significant interest from global CPET manufacturers, which could lead to broader commercial collaborations.
A recent 100-case proof-of-concept study conducted at the University of Washington showed that CPETWise significantly improved user satisfaction, with an average score of 4.5 out of 5. Moreover, the software reduced CPET interpretation time by more than 50%. According to Professor Yoni Buber of the University of Washington, "CPETWise dramatically improves efficiency by generating rapid, highly accurate reports. It also provides immediate access to raw data and standardized CPET graphical panels, while automatically identifying the primary limiting factor, giving clinicians faster and more actionable insights."
CPETWise is currently being deployed at leading institutions worldwide, including Columbia University, the University of Washington, UCLA, Sheba Medical Center, and Ichilov Medical Center. The software's successful deployment underscores its potential to revolutionize the way cardiopulmonary exercise testing is conducted and interpreted.
Looking ahead, Medibyt plans to expand its commercial presence beyond the United States into additional international markets. The company also intends to develop its next-generation machine-learning capabilities, having recently achieved promising initial classification results. Medibyt has access to approximately 4,000 retrospective CPET records interpreted by leading CPET experts, which will support ongoing algorithm development and validation.
In addition to its current focus on CPET, Medibyt is exploring opportunities to extend its technology into other cardiopulmonary diagnostic tests, such as spirometry and BodyBox pulmonary function testing. The company also aims to apply its technology in the sports medicine and performance markets, expanding its impact across various healthcare sectors.
"With FDA clearance in hand, we are well-positioned to advance our mission of making advanced cardiopulmonary diagnostics more accessible and practical," said Inbar. "We are excited about the potential of CPETWise and look forward to furthering our collaborations with leading global manufacturers and healthcare organizations."