FDA approves Anumana’s pulmonary hypertension algorithm

The algorithm integrates with EHR systems and ECG platforms, operating within the health system without external data transfer.

Anumana has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ECG-AI pulmonary hypertension (PH) detection algorithm, a software-as-a-medical-device (SaMD).

The algorithm is designed to identify early signs of PH using standard 12-lead electrocardiograms (ECGs). It is now accessible in a wide range of care settings.

A progressive pulmonary vascular disease, PH is estimated to affect up to 1% of the worldwide population.

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