Noninvasive AI Tool Enables Pressure-Guided Heart Failure Management

Heart failure often progresses to acute decompensation as fluid builds up, leading to hospitalizations and frequent readmissions. Pulmonary capillary wedge pressure (PCWP) is a key hemodynamic marker that can rise before symptoms appear, but measuring it has traditionally required invasive catheterization or implanted sensors, limiting routine use. A newly authorized system now estimates pulmonary capillary wedge pressure noninvasively, enabling pressure-guided heart failure management without invasive monitoring.

Cardiosense (Chicago, IL, USA) received U.S. Food and Drug Administration (FDA) De Novo classification for its PCWP Analysis Software, described as the first noninvasive, artificial intelligence–powered tool to provide this critical heart pressure reading. The authorization is intended to support clinicians who manage heart failure by providing data to improve therapy and avoid prolonged hospitalizations. Cardiosense’s CardioTag chest‑worn wearable sensor, which supplies the physiologic signals used by the software, previously obtained 510(k) clearance in July 2025, and both products are authorized for marketing in the United States as Class II medical devices.

The PCWP Analysis Software uses AI to generate highly precise estimates of PCWP from signals captured by a small wearable sensor worn on the chest. By enabling pressure estimation without a catheter or implanted device, the system is designed to detect rising filling pressures earlier and support more proactive management decisions. The software is indicated for adult patients with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction of 40% or less, and New York Heart Association (NYHA) Class II, III, or IV symptoms.

Details of the technology were first published in the JACC Heart Failure and presented at the American Heart Association’s 2024 Scientific Sessions, where it demonstrated accuracy comparable to implanted pressure sensors. The company characterizes the platform as first‑in‑class for noninvasive estimation of this metric to guide care inside and outside the hospital.

"This De Novo classification represents a transformative milestone for Cardiosense and a significant leap forward in our mission to redefine heart failure care," said Eric Meizlish, Chief Executive Officer. "Our 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 those living with heart failure."

"Being the first to noninvasively estimate these critical cardiac pressures is a technical achievement that is the culmination of years of multidisciplinary research and engineering," said Omer Inan, PhD, Co-Founder and Chief Scientific Officer. "By offering this critical data noninvasively, we have the potential to bring pressure-guided care to patients with heart failure, whether they are inside or outside the walls of the hospital. This milestone reflects the dedication of our entire team to pushing the boundaries of what is possible in the mission of patient-first innovation."

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