Cardiosense wins FDA De Novo for noninvasive PCWP software

Cardiosense said the FDA has granted De Novo classification for its PCWP Analysis Software, clearing a new regulatory pathway for a first-in-class tool that estimates pulmonary capillary wedge pressure noninvasively in adults with heart failure with reduced ejection fraction. The software works with the company’s CardioTag wearable chest sensor, which previously received 510(k) clearance in July 2025, and is authorized for use in adults with LVEF of 40% or less and NYHA class II, III, or IV symptoms. The FDA’s De Novo database lists the device as DEN250057, with a decision date of May 22, 2026, and Cardiosense announced the decision publicly on May 27, 2026. (accessdata.fda.gov)

Why it matters: While this is a human health device rather than a veterinary product, it’s still relevant to veterinary professionals tracking how AI-enabled monitoring tools are moving through regulators. The authorization creates a new class II category for noninvasive PCWP estimation, a notable step for wearable, algorithm-driven hemodynamic assessment. It also shows how companies are pairing cleared hardware with separately authorized software to bring more advanced physiologic monitoring into clinical workflows. (medicaleconomics.com)

What to watch: Watch for the FDA decision summary, commercial rollout details, and any future Cardiosense expansion into additional heart failure algorithms, including HFpEF-focused tools. (fda.gov)