Hexoskin Medical System Receives FDA 510(k) Clearance for Long-Term ECG and Respiratory Monitoring

The new FDA-cleared smart shirt enables long-term continuous ECG and respiratory monitoring, transforming remote patient care and clinical trials in the U.S. 

We are thrilled to announce a major milestone in digital health: the Hexoskin Medical System (HMS) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

This clearance for our medical-grade biometric smart garment and secure data management platform officially establishes it as an FDA-cleared smart shirt. It is now cleared for use in the United States to record, store, and analyze electrocardiogram (ECG), respiratory, and activity signals continuously in ambulatory patients.

This marks a new era for remote patient care and clinical research, enabling a shift from short-term snapshots to a long-term, holistic view of patient health.

Beyond the Holter: A New Era in Cardiopulmonary Monitoring

For decades, monitoring patients' heart and lung function outside the hospital has been a challenge. Traditional Holter monitors are typically limited to short strips of ECG recording. This creates a significant blind spot, as many clinically important events—such as transient arrhythmias or abnormal breathing patterns—are infrequent and easily missed in such a short window.

The Hexoskin Medical System is the definitive Holter monitor alternative for these situations. It provides a long-term, discreet, and continuous ECG monitor that patients can comfortably wear without requiring a setup by a technician. The HMS garment captures continuous ECG and respiratory monitoring data simultaneously, providing a comprehensive, real-world view of a patient's health in daily activities.

A New Standard for FDA-Cleared Real-World Patient Monitoring

With this clearance, the Hexoskin Medical System is now a premier FDA-cleared real-world patient monitoring system, offering a powerful tool for ambulatory cardiopulmonary monitoring.

This opens the door to better manage chronic conditions. It provides clinicians with a new remote monitoring solution for cardiovascular diseases and a better tool for monitoring COPD and asthma patients. The system's ability to provide longitudinal data passively is also ideal for at-home atrial fibrillation monitoring and recording other transient arrhythmias that traditional methods would miss.

As our CEO and co-founder, Pierre-Alexandre Fournier, stated: “The ability to measure both cardiac and respiratory signals continuously provides a comprehensive picture of patient health in their daily lives. This is a game changer for remote care, decentralized clinical trials, and the development of digital biomarkers for chronic diseases”

Transforming Clinical Trials With Real-World Data

This clearance is also a transformative tool for our pharmaceutical and research partners. The Hexoskin Medical System can now be deployed in regulated U.S. clinical trials to collect real-world evidence data with clinical-grade accuracy. The HMS delivers clinical-grade 3-lead ECG, heart rate, respiratory rate, and activity data directly from the patient's home environment, improving the reporting of endpoints and reducing patient burden.

Hexoskin research tools, such as the Hexoskin OneView clinical dashboard, also include a software platform designed for AI-based digital biomarker discovery, enabling new phenotyping strategies in cardiology, pulmonology, neurology, and rare disease research. The continuous data can improve endpoint sensitivity, reduce patient burden, and support remote trial models that are more inclusive and cost-effective.

Hexoskin is driving the next generation of AI-based digital biomarker discovery by extending our clinical platform beyond traditional cardiopulmonary monitoring. We are strategically focused on developing novel, clinically relevant endpoints in complex and underserved therapeutic areas, including rare diseases like Rett syndrome, and neurological disorders such as epilepsy. Our partners leverage the Hexoskin platform’s ability to collect continuous, high-fidelity physiological data, providing an objective, real-world window into disease progression and treatment efficacy that traditional methods often miss.

As a validated digital biomarker development platform, it provides the high-fidelity wearable sensors for clinical trials that researchers need. This technology is a cornerstone of modern decentralized clinical trial technology, enabling more inclusive, cost-effective, and accurate remote patient monitoring for clinical trials.

A Brighter Future for Millions

Globally, cardiovascular and chronic respiratory diseases remain the leading causes of death, affecting hundreds of millions of people and claiming millions of lives annually. In the U.S. alone, the burden is staggering: nearly 128 million adults live with cardiovascular disease, while over 50 million struggle with asthma or COPD—many of whom remain undiagnosed. This creates an unsustainable strain on families and the healthcare system, driven by costly, repeat hospitalizations that could be avoided with better data and a better patient experience.

The FDA-cleared Hexoskin Medical System provides the solution needed to bring clinical-grade monitoring into the home, with comfort and usability. By enabling continuous, clinical-grade monitoring of cardiac and respiratory function, we empower providers to intervene earlier to prevent complications, improving patient outcomes while reducing the overall cost of care.

To learn more about the Hexoskin Medical System and its capabilities for remote patient monitoring or clinical trials, contact our team today.

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