FDA granted Cardiosense's De Novo request for its PCWP Analysis Software on May 22. The grant, DEN250057, creates a new Class II regulation at 21 CFR 870.1150, product code SIF, for software that estimates cardiac pressures. FDA received the request on November 17, 2025, so the review ran 186 days. Cardiosense announced it on May 27.
The software works with CardioTag, a chest-worn sensor cleared under a 510(k) in July 2025. It is indicated for adults with heart failure with reduced ejection fraction, an LVEF of 40% or less, and NYHA class II to IV symptoms. Cardiosense calls it the first noninvasive tool to estimate pulmonary capillary wedge pressure. Clinicians otherwise get that number from right heart catheterization or an implanted sensor. Validation data published in JACC: Heart Failure showed accuracy comparable to implanted pressure sensors.
Cardiosense grew out of research at Northwestern and Georgia Tech. It closed a $15.1M Series A in December 2022 led by Broadview Ventures and Hatteras Venture Partners. CEO Eric Meizlish said the aim is more frequent therapy adjustments that keep patients out of the hospital. Algorithms for heart failure detection and for preserved ejection fraction are next. Splitting the hardware 510(k) from the software De Novo let the sensor ship first and confined the novel claim to one narrower submission.