Acorai’s Non-Invasive Intracardiac Pressure Monitor Gains FDA Breakthrough Nod

Acorai, a Swedish startup manufacturer, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Heart Monitor.
 
The device non-invasively estimates diastolic pulmonary artery pressure (dPAP), systolic pulmonary artery pressure (sPAP), and mean pulmonary artery pressure (mPAP) in patients with Stage C heart failure who were referred for hemodynamic monitoring.
 
Acorai’s non-invasive intracardiac pressure monitoring (IPCM) device is under development. Using patented hardware and a proprietary machine learning system, it’s intended to be a companion test alongside standard-of-care assessment in the hospital or clinic to spot hemodynamic congestion and support personalized heart failure treatment.
 
The breakthrough status application was supported with preliminary data of 281 patients from a 400-patient Swedish pilot study. The study showed “strong correlation” to invasive, gold-standard pulmonary pressure measurements.
 
Acorai has obtained ethics approval in five countries (including the U.S.) to conduct a 1,200-patient study to ensure the device is generalizable across a global heart failure population.
 
Acorai’s CEO and co-founder Filip Peters told the press, “We could not be more delighted with the decision from the FDA, and it constitutes a huge milestone for us as a company. Congratulations to the entire Acorai team who have worked hard to enable this.”
 
Kasper Bourdette, COO and co-founder, added that “receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision. This provides further signaling that we are on the right path and motivation for the [Acorai] team to take the device to approval in the coming few months.”