FDA Grants De Novo Status to Cardiosense PCWP Software for HFrEF

The US Food and Drug Administration (FDA) has granted de novo classification to the PCWP Analysis Software, a noninvasive AI–enabled tool to estimate pulmonary capillary wedge pressure (PCWP) in selected adults with heart failure (HF).1

Announced by parent company Cardiosense on May 27, 2026, the new authorization applies to adult patients with HF with reduced ejection fraction (HFrEF), left ventricular ejection fraction ≤40%, and New York Heart Association (NYHA) functional class II, III, or IV symptoms.1

“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, Chief Executive Officer of Cardiosense, said in a 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.”1

Mechanical Function

The PCWP Analysis Software is designed to estimate PCWP using data collected from a small wearable sensor worn on the chest. The company described the software as an AI-based algorithm intended to provide clinicians with a noninvasive estimate of a hemodynamic measure traditionally obtained via invasive right heart catheterization or implanted pressure-monitoring technology.1

Additionally, the press release announced that the PCWP Analysis Software and its CardioTag wearable sensor have been authorized for marketing as class II medical devices in the United States. The CardioTag wearable sensor previously received FDA 510(k) clearance in July 2025.1

The regulatory indication is narrower than the broader heart failure population. It is limited to adults with HFrEF, defined in the announcement as LVEF of 40% or less, and symptomatic disease corresponding to NYHA functional classes II through IV. Current US heart failure guidelines use LVEF categories, including HFrEF at ≥40%, as part of classification and treatment frameworks, but the company announcement did not report whether the software was evaluated across different care settings or compared with changes in clinical outcomes.2

PCWP Estimation and Prior Evidence

PCWP is used clinically to estimate left-sided filling pressures and congestion, primarily serving as a marker of fluid buildup in patients with HF. Elevated PCWP can precede symptomatic decompensation, but the release did not provide patient-level outcome data showing that use of the software reduces hospitalization, accelerates discharge, or improves quality of life.

The technology was previously published in JACC: Heart Failure and presented at the American Heart Association’s 2024 Scientific Sessions. The press release stated that the approach demonstrated accuracy comparable to that of implanted pressure sensors.1

Pressure-guided heart failure management has been studied previously with implanted pulmonary artery pressure sensors. In the CHAMPION randomized trial, wireless pulmonary artery pressure monitoring was associated with fewer heart failure hospitalizations compared with usual care in patients with NYHA class III heart failure and prior hospitalization. However, those data were generated with an implanted device and pulmonary artery pressure monitoring, not with noninvasive PCWP estimation software. The Cardiosense authorization therefore represents a distinct device category and should not be interpreted as evidence of identical clinical effects.3

Next Steps for the PCWP Software

Cardiosense stated its intention to introduce additional algorithms for heart failure detection and management of heart failure with preserved ejection fraction in the future. Those future indications have not been described as FDA-authorized in the release. The current regulatory scope remains adult HFrEF with LVEF of 40% or less and NYHA class II to IV symptoms.1

For clinicians evaluating the announcement, the main unresolved questions include how the software performed across body habitus, rhythm status, comorbidity burden, and decompensated vs stable HF populations; whether estimates maintain accuracy longitudinally; and whether use of the data changes outcomes when incorporated into care pathways. The company announcement also establishes US marketing authorization for the software as a class II device.1

“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, co-founder and chief scientific officer of Cardiosense, 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.”1

References

1. Cardiosense receives FDA De Novo classification for novel cardiac technology designed to improve care for patients with heart failure. Business Wire. May 27, 2026. https://www.businesswire.com/news/home/20260527688592/en/Cardiosense-Receives-FDA-De-Novo-Classification-for-Novel-Cardiac-Technology-Designed-to-Improve-Care-for-Patients-with-Heart-Failure

2. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063

3. Abraham WT, Adamson PB, Bourge RC, et al; CHAMPION Trial Study Group. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet. 2011;377(9766):658-666. doi:10.1016/S0140-6736(11)60101-3