The Food and Drug Administration has given clearance to AliveCor’s next generation of interpretive ECG algorithms, used in personal cardiology devices to support telemedicine.
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 FDA clearance provides detail including:
- A “Sinus Rhythm with Premature Ventricular Contractions (PVCs)” determination if two or more ventricular ectopic beats are detected. PVCs are a common occurrence where extra heartbeats originate in the bottom chamber of the heart and occur sooner than the next expected regular heartbeat.
- A “Sinus Rhythm with Supraventricular Ectopy (SVE)” determination if narrow-complex ectopy, such as premature atrial contractions (PACs), are detected. PACs are similar to PVCs, but these beats originate in the top chamber of the heart.
- A “Sinus Rhythm with Wide QRS” determination for QRS intervals of 120ms or longer. Wide QRS indicates the activation of the bottom chamber of the heart is taking longer than expected. This could indicate a bundle branch block in which there is a delay in the passage of heart’s electrical signals along the bottom of the heart.
- A reduced number of “unclassified” readings, 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 and fewer false negatives.
- 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 and the Kardia Heart Health Report, a cardiologist-backed patient heart risk assessment report.
The company also offers a professional ambulatory monitoring service, supporting use of the AliveCor six-lead ECG device in non-acute settings or at home.
The new determinations and services will be available in 2021.