Cardiosense, a healthcare technology company focused on heart failure care, today announced that the U.S. Food & Drug Administration (FDA) has granted De Novo classification for its PCWP Analysis Software™, a first-in-class technology to estimate a key indicator of heart health noninvasively. With this authorization, Cardiosense has a clear path forward in supporting clinicians who manage heart failure by providing critical data to improve therapy and avoid prolonged hospitalizations.
For patients with heart failure, fluid buildup is the leading cause of symptomatic decompensation and hospitalization. Pulmonary capillary wedge pressure (PCWP), a key indicator of fluid buildup, often rises well before symptoms appear, creating a critical window to intervene with targeted treatment before a patient’s condition deteriorates. Until now, PCWP could only be measured invasively with a catheter or implant placed inside the heart. However, with their PCWP Analysis Software, Cardiosense leverages AI to provide clinicians with highly precise estimation of this value using only a small wearable sensor worn on the chest, enabling earlier detection and more proactive heart failure management.
“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.”
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.
“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.”
The PCWP Analysis Software is indicated for use in adult patients diagnosed with heart failure with reduced ejection fraction (HFrEF), a Left Ventricle Ejection Fraction (LVEF) ≤ 40%, and New York Heart Association (NYHA) Functional Class II, III, or IV symptoms. This authorization follows the FDA 510(k) clearance of the company’s CardioTag™ wearable sensor in July 2025.
Cardiosense is now bringing its heart failure monitoring solution to patients and care providers, with the intention to introduce a series of new algorithms to detect heart failure and manage heart failure with preserved ejection fraction (HFpEF) in the future.
About Cardiosense
Cardiosense is a leading healthcare technology company redefining detection, monitoring, and management of cardiac disease. Built on over a decade of clinical and scientific research, the company is developing novel wearable sensors and machine learning algorithms that translate raw physiological signals into clinically actionable parameters to detect early signs of cardiac disease, guide personalized therapy, and improve patient outcomes. For more information, visit www.cardiosense.com and follow Cardiosense on LinkedIn and X.
The CardioTag™ device and PCWP Analysis Software have been authorized to market as class II medical devices in the US.
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