Acorai
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 for regulatory approval to the…
Read More
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…
Read More
HELSINGBORG, Sweden, Nov. 1, 2022 /PRNewswire/ — Acorai, a Swedish-based medical device start-up, announces endorsements from two major healthcare players as they prepare the Acorai Heart Monitor for regulatory submission and clinical use within the next 18 months. Acorai is developing a first-of-its-kind, scalable medical device for non-invasive intracardiac pressure monitoring to improve heart failure…
Read More