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.