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