Cardiosense Wins FDA De Novo Nod for PCWP Analysis Software

Cardiosense has received U.S. Food and Drug Administration (FDA) de novo classification for its PCWP Analysis Software, a tech that estimates a key indicator of heart health noninvasively.

Fluid buildup is the main cause of symptomatic decompensation and hospitalization for heart failure patients. Pulmonary capillary wedge pressure (PCWP) is a key indicator of fluid buildup and often rises well before symptoms appear, creating a critical window to intervene with targeted treatment before condition deteriorates. Previously, PCWP could only be measured invasively with a catheter or implant placed in the heart.

Cardiosense’s PCWP Anaylsis Software leverages artificial intelligence (AI) to offer a precise estimation of this value using a small sensor worn on the chest. This enables earlier detection and more proactive heart failure management, the company said.

“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, CEO of Cardiosense. “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 in the Journal of the American College of Cardiology: Heart Failure and presented at the American Heart Association’s 2024 Scientific Sessions. It showed accuracy comparable to implanted pressure sensors.

The software is indicated for adult patients diagnosed with heart failure with reduced ejection fraction (HFrEF), a left ventricle ejection fraction (LVEF) less than or equal to 40%, and New York Heart Association (NYHA) Functional Class II, III, or IV symptoms. The authorization follows the FDA 510(k) clearance of the company’s CardioTag wearable sensor last July.

“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, Ph.D., Cardiosense’s 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.”