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BioWorld - Tuesday, November 11, 2025
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Home » Acorai receives FDA breakthrough device designation for its Heart Monitor
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Acorai receives FDA breakthrough device designation for its Heart Monitor

Aug. 16, 2023
By Shani Alexander
Acorai AB received a U.S. FDA breakthrough device designation for its Heart Monitor, a noninvasive intracardiac pressure monitoring device for patients with heart failure. The Acorai Heart Monitor can estimate diastolic pulmonary artery pressure, systolic pulmonary artery pressure and mean pulmonary artery pressure in patients with Stage C heart failure who have been referred for hemodynamic monitoring.
BioWorld MedTech Regulatory Cardiovascular U.S. FDA

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