Acorai is a Swedish medical device startup developing a first-of-its-kind, scalable device for non-invasive intracardiac pressure monitoring to improve heart failure management for over 64 million patients worldwide. The company's heart monitor uses a patented SAVE Sensor System that integrates seismic, acoustic, visual, and electrical sensors to collect data, which is then analyzed by proprietary machine learning models to estimate diastolic, systolic, and mean pulmonary artery pressures.
Acorai's heart monitor has demonstrated accuracies comparable to invasive gold-standard measurements in a 400-patient feasibility study conducted in June 2023. The non-invasive, handheld device allows healthcare professionals to quickly obtain intracardiac pressure readings by simply holding it against the patient's chest, without requiring specialized training or dedicated equipment.
In August 2023, the company received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its heart monitor. Acorai aims to submit the device for FDA clearance and CE-marking in 2024, with full commercial launch expected in 2025. The company has initiated the CAPTURE-HF global clinical trial across 11 sites in several countries to validate the device's performance on 1,200 patients undergoing catheterization procedures.
By using this site, you agree to allow SPEEDA Edge and our partners to use cookies for analytics and personalization. Visit our privacy policy for more information about our data collection practices.