FDA Clears AliveCor’s New Algorithm Suite for AI-Based Personal ECG Technology

November 23, 2020—AliveCor announced FDA 510(K) clearance for the company’s next generation of interpretive electrocardiogram (ECG) algorithms. AliveCor’s KardiaMobile and KardiaMobile 6L devices, along with the Kardia app, allow users to take a 30-second ECG and receive instant determinations of multiple cardiac conditions.

The new FDA clearance positions AliveCor to deliver artificial intelligence–based remote cardiological services for the vast majority of cases when cardiac patients are not in front of their doctor. The new determinations and services will be available in 2021, advised AliveCor.

According to the company, the new clearance includes:

• A “sinus rhythm with premature ventricular contractions (PVCs)” determination if two or more ventricular ectopic beats are detected
• A “sinus rhythm with supraventricular ectopy” determination if narrow-complex ectopy, such as premature atrial contraction, is detected
• A “sinus rhythm with wide QRS,” determination for QRS intervals of 120 ms or longer
• A reduced number of “unclassified” readings, thereby giving users more reliable insight into their heart rhythms
• Improved sensitivity and specificity on the company’s “normal” and “atrial fibrillation” algorithms, giving users fewer false positives, fewer false negatives, and even greater confidence in Kardia determinations
• New visualizations, including average beat, PVC identification, and a tachogram

AliveCor expects this new suite of advanced determinations will augment telehealth services and provide the technology foundation for a new range of professional and consumer services including the launch of:

• Advanced ECG determination services within KardiaCare, the company’s remote heart care service for consumers
• The Kardia Heart Health Report, a cardiologist-backed patient heart risk assessment report
• A professional ambulatory monitoring service, using the AliveCor six-lead ECG device at home, bringing greater comfort and convenience over legacy technologies
• Chronic heart disease management, which combines human-backed and digital care plans to manage the heart health of high-risk employee populations