Kardia 12L vs Anumana

A cardiology group that already records 12-lead ECGs and wants reduced-EF, pulmonary hypertension or amyloid notifications in the EHR is Anumana's customer. Its ECG-AI reads a standard 10-second 12-lead recording and flags low ejection fraction, pulmonary hypertension or cardiac amyloidosis. Its clearances include K232699 (September 2023), K250652 (July 2025), K252360 (March 2026) and K253801 (April 2026). The vendor cites 90.2% sensitivity and 85.1% specificity for low EF. Pricing is demo-only, and the homepage cites CPT III codes.

AliveCor sells the recorder with its AI to clinicians who need point-of-care 12-lead capture. Kardia 12L is listed at $2,295 with the KardiaStation app, KardiaPro access and a 3-year warranty, and the page does not say whether that price recurs. The vendor's AI page describes six arrhythmias including AFib and counts 39 FDA-cleared determinations. The AI page names arrhythmias and Anumana's clearances name reduced EF, pulmonary hypertension and amyloidosis, so a group whose question is rhythm on a portable recorder looks at AliveCor, and one whose question is those three conditions on existing ECGs looks at Anumana.