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

By Acorai / August 16, 2023

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…

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

By Acorai / August 12, 2023

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…

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Heart Failure start-up, Acorai, wins US and UK healthcare support

By Acorai / November 1, 2022

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…

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