Cardiosense has received FDA De Novo classification for its PCWP Analysis Software, a first-in-class technology that noninvasively estimates pulmonary capillary wedge pressure, a key indicator of fluid buildup in heart failure patients. The AI-powered system uses data from a small wearable chest sensor to provide measurements previously obtainable only through invasive catheters or implants. The technology enables earlier detection of fluid buildup before symptoms appear, allowing clinicians to intervene proactively. Published in the Journal of the American College of Cardiology: Heart Failure, the system demonstrated accuracy comparable to implanted pressure sensors. The software is approved for adult patients with heart failure with reduced ejection fraction, following FDA 510(k) clearance of Cardiosense's CardioTag wearable sensor in July 2025.

Cardiosense Receives $15.1M Series A Round Back to HomeCHICAGO, IL, Cardiosense announced that it has raised $15.1 million in Series A funding.Cardiosense, a digital health company leveraging artificial intelligence and multi-sensor devices to enable early detection of cardiovascular disease, announced today that it has raised $15.1 million in Series A funding, co-led by Broadview Ventures and Hatteras Venture Partners, with participation from Laerdal Million Lives Fund, OSF Ventures, UnityPoint Health Ventures, and Portal Innovations. The capital will be used to support team expansion, accelerate product development, and fund an expansive heart failure study.Cardiosense is building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The Company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms to detect early signs of cardiovascular disease, inform personalized therapy, and improve patient outcomes.(c)2011-2020 by Massinvestor, Inc. For contact info, please check out our about page