CHICAGO, Ill., May 29, 2026
Cardiosense has achieved a major regulatory milestone with the U.S. Food and Drug Administration (FDA) granting De Novo classification to its PCWP Analysis Software™, a first-in-class artificial intelligence-powered technology designed to improve the management of patients living with heart failure. The authorization marks the first noninvasive system capable of estimating pulmonary capillary wedge pressure (PCWP), a critical indicator of cardiac health and fluid buildup traditionally measured through invasive procedures. By combining advanced machine learning algorithms with the company’s CardioTag™ wearable sensor, the innovative platform provides clinicians with highly actionable cardiovascular data without requiring implanted devices or catheter-based monitoring. The FDA decision positions Cardiosense at the forefront of next-generation cardiac monitoring and highlights the growing role of artificial intelligence in transforming cardiovascular care.
AI-Powered Technology Brings Noninvasive Heart Pressure Monitoring
For millions of patients suffering from heart failure, fluid accumulation remains one of the leading causes of worsening symptoms, emergency care visits, and hospitalization. Pulmonary capillary wedge pressure is widely recognized as one of the most important physiological indicators for identifying early fluid overload and cardiac decompensation. Until now, accurate PCWP measurements required invasive catheterization procedures or implanted pressure-monitoring devices, limiting access to continuous monitoring.
Cardiosense’s newly authorized PCWP Analysis Software™ changes this paradigm by leveraging artificial intelligence to estimate cardiac filling pressures using physiological signals collected from a lightweight chest-worn wearable sensor. This noninvasive approach allows clinicians to monitor patients more frequently, identify worsening heart failure earlier, and make timely treatment adjustments before severe symptoms emerge. By detecting physiological changes before hospitalization becomes necessary, the technology has the potential to improve outcomes while reducing healthcare costs associated with recurrent admissions.
Clinical Validation Demonstrates Accuracy Comparable to Implanted Sensors
Advertisement
The FDA’s De Novo authorization was supported by extensive clinical research demonstrating the technology’s ability to accurately estimate cardiac pressure measurements. Findings published in the Journal of the American College of Cardiology: Heart Failure and presented at the American Heart Association Scientific Sessions 2024 showed that Cardiosense’s platform achieved accuracy comparable to implanted pressure-monitoring systems currently used in advanced heart failure management.
Researchers highlighted the significance of providing pressure-guided care through a completely noninvasive solution, enabling broader adoption across hospitals, outpatient clinics, and remote patient monitoring programs. The technology is specifically indicated for adults diagnosed with heart failure with reduced ejection fraction (HFrEF), including patients with a left ventricular ejection fraction of 40% or lower and New York Heart Association Class II, III, or IV symptoms. The authorization follows the FDA’s earlier 510(k) clearance of the CardioTag wearable sensor in 2025, creating a comprehensive platform capable of delivering clinically meaningful cardiovascular insights.
Regulatory Milestone Accelerates Future Cardiac Innovation
The De Novo classification establishes a new regulatory category for AI-driven noninvasive cardiac pressure estimation and provides a foundation for future product expansion. Cardiosense plans to deploy the technology across healthcare systems to support earlier intervention, personalized treatment optimization, and improved patient outcomes. Company leaders emphasized that pressure-guided heart failure management has historically been available only to a limited number of patients due to the invasive nature of traditional monitoring approaches. By democratizing access to these critical measurements, Cardiosense aims to transform the standard of care for heart failure management both inside and outside hospital settings.
Looking ahead, the company intends to introduce additional algorithms designed to support the detection of heart failure and management of heart failure with preserved ejection fraction (HFpEF), further expanding the capabilities of its digital cardiovascular platform. As healthcare increasingly embraces wearable technology and artificial intelligence, Cardiosense’s FDA-authorized innovation represents an important advancement in delivering proactive, data-driven care for one of the world’s most prevalent and costly chronic diseases.
Source: Cardiosense press release
