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Acorai’s Heart Monitor Receives the US FDA’s Breakthrough Device Designation for Heart Failure

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Acorai

Acorai’s Heart Monitor Receives the US FDA’s Breakthrough Device Designation for Heart Failure

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  • The US FDA has granted Breakthrough Device Designation for Acorai's Heart Monitor, a device for non-invasive estimation of diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in patients with stage C HF who have been referred for hemodynamic monitoring
  • It is designed as a companion test for qualified healthcare professionals. To detect hemodynamic congestion and support HF personalized treatment, the device can be used in conjunction with SoC assessment in a clinical setting or hospital
  • The application was based on the preliminary data from a Swedish pilot study incl. 281 out of 400 patients showed a strong correlation to the standard measurements of pulmonary pressure

Ref: PR Newswire | Image: Acorai

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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