Cardiosense has received De Novo classification from the U.S. Food and Drug Administration for its PCWP Analysis Software™, a new technology designed to help clinicians monitor heart failure patients through non-invasive assessment of pulmonary capillary wedge pressure.
PCWP is an important indicator of fluid build-up in the body and often increases before heart failure symptoms become noticeable. Traditionally, measuring this value has required invasive procedures involving catheters or implanted devices.
Cardiosense’s software uses artificial intelligence and data collected from a wearable chest sensor to estimate PCWP without the need for invasive monitoring.
The technology is intended to support healthcare professionals in identifying early signs of worsening heart failure, allowing treatment adjustments before a patient’s condition deteriorates and potentially reducing hospital admissions and lengthy stays.
The software’s performance was previously reported in a study published in the Journal of the American College of Cardiology: Heart Failure and was also presented at the American Heart Association’s 2024 Scientific Sessions.
Findings showed accuracy levels comparable to implanted pressure-monitoring devices.
The FDA authorisation applies to adult patients with heart failure with reduced ejection fraction and follows the agency’s 510(k) clearance of the company’s CardioTag™ wearable sensor in 2025.
Cardiosense plans to expand its heart failure monitoring capabilities through additional algorithms in the future.
