Cardiosense Receives FDA De Novo Classification for AI-Powered Heart Failure Monitoring Software

Chicago, Illinois-based Cardiosense announced that the US Food and Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software, which is designed to estimate noninvasively pulmonary capillary wedge pressure (PCWP), a key indicator of heart health.

For patients with heart failure, fluid buildup is the leading cause of symptomatic decompensation and hospitalization. Pulmonary capillary wedge pressure often rises well before symptoms appear, creating a window to intervene with targeted treatment before a patient’s condition deteriorates. Until now, PCWP could only be measured invasively with a catheter or an implant placed inside the heart. Cardiosense’s software uses artificial intelligence to estimate this value using a small wearable sensor worn on the chest, enabling earlier detection and more proactive heart failure management. The technology was first published in the Journal of the American College of Cardiology: Heart Failure and presented at the American Heart Association’s 2024 Scientific Sessions, where it demonstrated accuracy comparable to implanted pressure sensors.

Eric Meizlish, Chief Executive Officer of Cardiosense, stated that the company’s technology empowers healthcare providers to make more informed and more frequent individualized therapy adjustments, ultimately aiming to prevent hospitalizations, accelerate discharge, and improve quality of life for patients. Dr. Omer Inan, Co-Founder and Chief Scientific Officer, added that being the first to noninvasively estimate these critical cardiac pressures is a technical achievement culminating from years of multidisciplinary research and engineering.

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