Acarix submits breakthrough designation request to FDA for heart failure diagnosis tool


Acarix has submitted a breakthrough designation request for its technology for heart failure diagnosis, Seismo, to the US Food and Drug Administration (FDA).

The new Acarix Seismo is an artificial intelligence (AI)-powered, non-invasive system that offers a simple, rapid risk assessment for patients with suspected heart failure in less than 10 minutes. The breakthrough submission is based on clinical data generated from the Seismo study performed in Denmark.

“I am very proud of this FDA submission, and we believe the Seismo System has the potential to radically improve early diagnosis of heart failure. The Seismo System provides AI-based rapid access to diagnostics information, which can help better guide optimal patient care and yield improved clinical outcomes faster. We are expecting a response from FDA in April,” said Helen Ljungdahl Round, CEO.

With this FDA breakthrough submission, Acarix intends to strengthen its leading position using AI based technology in cardiac care and patient management.


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