Two Al algorithms from Anumana received FDA (US Food and Drug Administration) clearance in early
2026 for something a standard 12-lead ECG has never been validated to do before: detect cardiac
amyloidosis and pulmonary hypertension (PH).[1]
Cardiac amyloidosis — in which amyloid protein deposits cause progressive myocardial stiffening and
diastolic dysfunction — is chronically underdiagnosed; published registry data show a median
diagnostic delay of over two years, with many patients waiting considerably longer.[15] PH carries a
similar story: a median delay of two to three years from first symptoms to diagnosis.[16] Both
algorithms flag patients who warrant further investigation and do not replace the imaging needed to
confirm the diagnosis. Neither is yet available outside the US.