FDA gives greenlight to new AI tool for managing heart failure patients
The U.S. Food and Drug Administration (FDA) has officially signed off on a new artificial intelligence (AI) tool to better track heart failure from Chicago-based Cardiosense.
PCWP Analysis Software was designed to estimate pulmonary capillary wedge pressure (PCWP), a known indicator of fluid buildup, in a noninvasive manner that does not require a catheter or an implant. Patients simply put on a small wearable sensor and the AI does the rest.
Fluid buildup is associated with significant risks in patients with heart failure, and this is the first AI-enabled software designed specifically to capture PCWP data.
“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,” Omer Inan, PhD, Cardiosense co-founder and chief scientific officer, said in a statement. “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.”
The FDA cleared PCWP Analysis Software through its De Novo classification. This pathway allows medtech companies to secure approval for novel technologies that are the first of their kind and carry a limited potential for risk.
“This De Novo classification represents a transformative milestone for Cardiosense and a significant leap forward in our mission to redefine heart failure care,” Eric Meizlish, Cardiosense CEO, said in the same statement. “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.”
PCWP Analysis Software is indicated for the management of adult patients with heart failure with reduced ejection fraction (HFrEF).
Back in July 2025, Cardiosense secured FDA clearance for its CardioTag device.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.