Acorai

Acorai is developing a first-of-a-kind non-invasive intracardiac pressure monitor for heart failure management. The device uses the SAVE Sensor System™ combining seismic, acoustic, visual, and electrical signals processed via proprietary machine learning models. It provides actionable insights directly through patient skin without invasive procedures. The company is undergoing large-scale clinical trials (e.g., CAPTURE-HF study with ~1200 patients). A previous generation study included ~400 patients. Their Heart Monitor received FDA Breakthrough Device designation in August 2023. Acorai aims for US market access by the end of 2025.