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FDA Grants Breakthrough Device Designation to Acorai’s Heart Monitor
The non-invasive device can be used to monitor the heart in a variety of ways.
The FDA has granted breakthrough device designation to Acorai’s Heart Monitor. The non-invasive device is designed for pressure monitoring and is meant to be used alongside standard-of-care assessment in a clinical setting.
The heart monitor can be used to measure diastolic pulmonary artery pressure, systolic pulmonary artery pressure, and mean pulmonary artery pressure.
The FDA granted the breakthrough designation based on the preliminary results from a 400-patient study in Sweden (Acorai’s home country). The preliminary data is based on the results of 281 patients and showed a strong correlation to the standard measurements of pulmonary pressure.
Acorai will conduct a larger study in the US which will include 1200 patients.
In a press release, Acorai’s CEO and co-founder Filip Peters said, “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."
