US' HMS gets FDA 510(k) clearance for smart shirt

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.

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.

“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, decentralised clinical trials, and the development of digital biomarkers for chronic diseases,” CEO and co-founder, Pierre-Alexandre Fournier, said.

This clearance is also a transformative tool for our pharmaceutical and research partners. The Hexoskin Medical System can now be deployed in regulated US 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, HMS said in a press release.

Hexoskin is driving the next generation of AI-based digital biomarker discovery by extending our clinical platform beyond traditional cardiopulmonary monitoring. The company is 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.

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 decentralised clinical trial technology, enabling more inclusive, cost-effective, and accurate remote patient monitoring for clinical trials.

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 US 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 hospitalisations 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.

ALCHEMPro News Desk (RR)