Medibyt's FDA Win: AI Platform to Reshape Cardiopulmonary Testing

HERZLIYA, Israel – September 01, 2026 – In a move poised to significantly alter the landscape of cardiopulmonary diagnostics, Israeli digital health company Medibyt announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its flagship platform, CPETWise. This clearance paves the way for the commercial launch of an artificial intelligence-driven system designed to automate and streamline one of medicine's most comprehensive, yet complex, diagnostic procedures.

The technology targets the Cardiopulmonary Exercise Test (CPET), a non-invasive assessment that provides a wealth of data on how a patient's heart, lungs, and muscles respond to exercise. While considered a gold standard for evaluating exercise capacity and identifying the root causes of symptoms like shortness of breath, CPET's clinical utility has been hampered by its complexity. Interpreting the test's myriad data points is a time-consuming process that demands deep expertise, often limiting its use to specialized academic centers. Medibyt aims to change that paradigm completely.

The AI Revolution in a Complex Diagnostic

At its core, CPETWise is a Software as a Service (SaaS) platform that leverages intelligent automation to transform the laborious task of CPET interpretation. Where clinicians once spent up to an hour meticulously analyzing graphs and raw data, Medibyt's system promises to generate a full, standardized report in as little as five minutes. This dramatic efficiency gain was validated in a 100-case proof-of-concept study at the University of Washington, which found the platform reduced interpretation time by over 50% while earning a high user satisfaction score of 4.5 out of 5.

"The current analysis and workflow platform dramatically improves efficiency in cardiopulmonary exercise testing by generating rapid, highly accurate reports," said Prof. Yoni Buber of the University of Washington, who was involved in the study. He noted that the system "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."

Crucially, the platform is not a "black box." It was designed to augment, not replace, clinical judgment. While the AI handles the heavy lifting of data processing and initial interpretation, the system ensures clinicians retain full visibility into the underlying physiological data, allowing them to verify the automated findings and apply their own expertise. This balance is key to building trust and driving adoption in a field where clinical oversight is paramount. The HIPAA-compliant, cloud-based architecture also enables secure remote access and collaboration, a critical feature for modern, distributed healthcare teams.

From FDA Clearance to U.S. Market Disruption

The FDA's 510(k) clearance (K260242), which classifies CPETWise as a "Calculator, Predicted Values, Pulmonary Function," is more than a regulatory hurdle; it's a commercial launchpad into the world's largest healthcare market. For Medibyt, this approval represents the culmination of years of development and clinical validation.

"Receiving FDA clearance for CPETWise is a transformative milestone for Medibyt," said Or Inbar, the company's CEO and Co-Founder. "It validates the significant work our team has completed and enables us to move forward with commercialization in the United States. Our goal is to make advanced cardiopulmonary diagnostics more accessible, scalable, and practical for everyday clinical use."

This strategic push is already gaining traction. The company has initiated a commercial pilot with a leading, unnamed U.S. CPET company to integrate CPETWise into its systems. Furthermore, Medibyt reports growing interest from global CPET equipment manufacturers, hinting at future collaborations that could embed its software directly into the hardware used by hospitals worldwide. This strategy of partnering with established players could significantly accelerate market penetration.

Democratizing Advanced Diagnostics

The most profound impact of Medibyt's innovation may lie in its potential to democratize access to advanced diagnostics. By simplifying the CPET workflow, CPETWise could empower a wider range of healthcare facilities, including community hospitals and smaller clinics, to offer this powerful test. This increased accessibility could lead to earlier and more accurate diagnoses for patients with unexplained exercise intolerance, heart failure, and other complex cardiopulmonary conditions.

One expert on the company's advisory board noted that while CPET is invaluable, its interpretation requires an in-depth knowledge of exercise physiology that not all practitioners possess. An AI-driven analysis platform, they explained, serves as a powerful support tool, enhancing consistency and providing a standardized framework that can elevate the quality of care across different settings. The deployment of demonstration environments at prestigious institutions like Columbia University, UCLA, and Sheba Medical Center already signals strong clinical interest and credibility.

A Glimpse into the Future: Beyond CPET

While the U.S. launch of CPETWise is the immediate focus, Medibyt is already looking toward the next frontier of innovation. The company is actively developing its next-generation machine-learning capabilities, leveraging a rich dataset of approximately 4,000 retrospective CPET records interpreted by leading experts. This data is the fuel for creating even more sophisticated algorithms for diagnostic classification and predictive analytics.

Medibyt's ambitions also extend beyond a single test. The company plans to apply its core automation technology to other essential cardiopulmonary diagnostics, including spirometry (which measures lung function) and BodyBox pulmonary function testing. This expansion would position the Israeli firm as a comprehensive platform provider for lung and heart diagnostics. In another strategic move, the company is targeting the sports medicine and performance markets, where precise analysis of athletic capacity is in high demand, opening up a significant commercial vertical outside of traditional clinical care.

With FDA clearance secured and a clear strategy for expansion, Medibyt is no longer just a promising startup; it is now a commercially viable contender at the intersection of medical technology and artificial intelligence, poised to bring a new level of efficiency and insight to a critical area of healthcare.