Tag: Acorai

ACORAI Presents Positive Results in 1,600-Patient CAPTURE-HF Study for its AI-Powered Non-Invasive Multi-Sensor Platform for Improved Heart Failure Patient Management

MINNEAPOLIS, Oct. 6, 2025 /PRNewswire/ — Acorai, a clinical-stage company pioneering non-invasive hemodynamic monitoring for heart failure management, this week announced topline results from the 1,600-patient CAPTURE-HF study (Machine-Learning Estimation of Pulmonary Capillary Wedge and…

Heart Failure start-up, Acorai, embarks on the next vital stage towards regulatory approval

HELSINGBORG, Sweden, Aug. 16, 2023 /PRNewswire/ – Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated as a breakthrough device by the US FDA in August 2023 and they aim to submit their heart monitor […]

Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor

HELSINGBORG, Sweden, Aug. 10, 2023 /PRNewswire/ — Acorai, a start-up medical device manufacturer from Sweden, today announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Acorai’s Heart Monitor, a device for the non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery […]