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FDA De NovoFDA De Novo. Stage 4 of 4 (Authorized)

FDA Grants De Novo to Cardiosense Software That Estimates Heart Pressure From a Wearable

The PCWP Analysis Software uses AI on data from the CardioTag chest sensor to estimate a congestion measure usually taken by catheter, in adults with reduced ejection fraction heart failure.

By News DeskMay 27, 20262 min read
Yellow pulmonary artery catheter with multiple colored lumens on its sterile packaging
A pulmonary artery catheter in its packaging, the invasive tool traditionally used to measure wedge pressure. Not a Cardiosense product. ICUnurses, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA De Novonew device type · DEN250057FDA De Novo. Stage 4 of 4 (Authorized)

The FDA granted this device through the De Novo pathway, used for new low-to-moderate-risk device types with no existing equivalent.

Key points

  • FDA granted De Novo DEN250057 to Cardiosense's PCWP Analysis Software on May 22, 2026; the company announced it on May 27.
  • The software estimates pulmonary capillary wedge pressure noninvasively from the CardioTag wearable chest sensor.
  • The indication is limited to adults with heart failure with reduced ejection fraction (LVEF of 40% or less) and NYHA class II-IV symptoms.

Cardiosense said on May 27 that the U.S. Food and Drug Administration has granted De Novo classification for its PCWP Analysis Software, an AI-based program that estimates pulmonary capillary wedge pressure without invasive procedures, as reported by Medical Economics and HCPLive.

The FDA's openFDA device database lists the grant as DEN250057, decided on May 22, 2026, for a request received on Nov. 17, 2025. It creates a new Class II device type, a software device system for estimation of cardiac pressures, under regulation 21 CFR 870.1150 with product code SIF.

What the software measures

Pulmonary capillary wedge pressure, or PCWP, is an indicator of fluid buildup in the lungs and heart that can signal worsening heart failure before symptoms appear, the company said. It has traditionally required right heart catheterization or an implanted pressure sensor. Cardiosense's software works with the company's CardioTag wearable chest sensor and uses AI to turn the sensor data into pressure estimates for clinicians. CardioTag received 510(k) clearance in July 2025.

The authorized use is narrow. The software is indicated for adults with heart failure with reduced ejection fraction, a left ventricular ejection fraction of 40% or less, and New York Heart Association class II, III or IV symptoms, according to both reports.

"This De Novo classification represents a transformative milestone for Cardiosense and a significant leap forward in our mission to redefine heart failure care," chief executive Eric Meizlish said in a statement. Co-founder and chief scientific officer Omer Inan said the company had the potential "to bring pressure-guided care to patients with heart failure, whether they are inside or outside the walls of the hospital."

Evidence and open questions

Cardiosense said research on the technology was published in JACC: Heart Failure and presented at the American Heart Association's 2024 Scientific Sessions, and that it showed accuracy comparable to implanted pressure sensors.

HCPLive noted that the announcement did not include patient-level outcome data showing that the software reduces hospitalizations, speeds discharge or improves quality of life, which the company named as aims. The outlet said earlier evidence for pressure-guided heart failure care, such as the CHAMPION trial, came from implanted pulmonary artery pressure sensors, a distinct device category.

The company said it plans to add algorithms for detecting heart failure and for managing heart failure with preserved ejection fraction. Those uses are not part of the current authorization.

Sources

  1. openFDA device record DEN250057: PCWP Analysis Software (Cardiosense, Inc.), U.S. Food and Drug Administration (openFDA), May 22, 2026
  2. Cardiosense receives FDA authorization for heart failure monitoring software, Medical Economics, May 27, 2026
  3. FDA Grants De Novo Status to Cardiosense PCWP Software for HFrEF, HCPLive, May 27, 2026