Cardiosense, a medical AI technology company, received FDA de novo classification for its pulmonary capillary wedge pressure analysis software, a noninvasive heart failure monitoring technology.
The software uses AI and a wearable chest sensor to estimate PCWP, a measure associated with fluid buildup in patients with heart failure. Until now, the measurement required an invasive catheter or implanted device, according to a May 27 news release.
The technology is intended to help clinicians identify worsening heart failure earlier and adjust treatment before hospitalization is needed. The software is indicated for adults with heart failure with reduced ejection fraction, a left ventricle ejection fraction of 40% or less, and New York Heart Association Class II, III or IV symptoms.
The FDA authorization follows the agency’s July 2025 clearance of the company’s CardioTag wearable sensor. Cardiosense plans to expand the platform with future algorithms focused on heart failure detection and management for patients with preserved ejection fraction, according to the release.
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