Swiss medical device start-up Acorai has received breakthrough device designation from the US Food and Drug Administration (FDA) for its heart monitor.
The intracardiac pressure monitor (IPCM) is intended to non-invasively estimate mean pulmonary artery pressure, diastolic pulmonary artery pressure and systolic pulmonary artery pressure in patients with Stage C heart failure (HF), who were recommended for haemodynamic monitoring.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Claimed to be the first of its kind, the IPCM device leverages a proprietary machine-learning system and patented hardware technology.
It is designed as a companion test for qualified healthcare professionals.
For detecting haemodynamic congestion and supporting HF personalised treatment, the device can be used in conjunction with standard-of-care assessment in a clinical setting or hospital.
Acorai chief operating officer and co-founder Kasper Bourdette said: “Receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled about the decision.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataPreliminary data from a Swedish pilot study involving 281 out of 400 patients has supported the breakthrough device application.
Acorai has obtained ethics approval in five countries, including the US, to conduct a larger study involving 1,200 patients.
This study aims to ensure that the device is generalisable across a global heart failure population.
Acorai 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.”
