FDA approves AI algorithm suite for personal ECG device
AliveCor announced its next-generation AI algorithms for ECG interpretation have received 510(k) clearance from the FDA.
The company’s algorithm (AI V2), along with its Kardia devices and the mobile app, allows users to take a 30-second ECG and receive instant determinations of multiple cardiac conditions, including atrial fibrillation, according to a press release.
"Kardia AI V2 is the most sophisticated AI ever brought to personal ECG," Priya Abani, CEO for AliveCor, said in the release. "This suite of algorithms and visualizations will provide the platform for delivery of new consumer and professional service offerings beyond AF, by allowing a much wider range of cardiac conditions to be determined on a personal ECG device."
According to the release, the algorithms are able to detect a sinus rhythm with premature ventricular contractions, a sinus rhythm with supraventricular ectopy and a sinus rhythm with wide QRS interval.
Additional features include:
- a reduced number of ‘Unclassified’ readings;
- improved sensitivity and specificity on the "Normal" and "Atrial Fibrillation" algorithms, showing fewer false positives and false negatives; and
- new visualizations for average beat, PVC identification and a tachogram.
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