Cardio-focused digital health company AliveCor landed FDA clearance for its new suite of interpretive ECG algorithms, dubbed the Kardia AI V2. This news comes just days after the company announced a $65 million Series E funding round.
The new clearance will is able to capture sinus rhythm with premature ventricular contractions, sinus rhythm with supraventricular ectopy and a sinus rhythm with wide QRS. The algorithm works on AliveCor’s KardiaMobile and KardiaMobile 6L devices, which even before this latest FDA clearance, have been able to take 30-second ECGs, and are hooked up to a corresponding app.
According to the company’s release, the algorithm will also reduce the number of unclassified readings, and has improved sensitivity and specificity on the company’s normal and atrial fibrillation algorithms. Users will also have new visualization tools that let them see heart beat average, PVC identification and tachogram.
WHY IT MATTERS
According to the CDC, heart disease is the leading cause of death in the United States. Heart disease costs the U.S. approximately $219 billion every year, the agency reports. Digital has been one way that tech companies and startups have pitched to help manage heart related conditions.
AliveCor is specifically pitching this new technology as a way to improve cardiac care and specifically telehealth services. It said that this tech will support its new product launches in a physician-backed heart risk assessment report, remote ECG readings, and chronic care management.
THE LARGER TREND
AliveCor has been in the heart health space for a number of years. More recently added an ECG subscription service to its product line. It has also worked in the device space. In 2019 it landed FDA clearance for the KardiaMobile 6L, its six-lead ECG device.
But AliveCor isn’t the only company working in the ECG space. Apple turned heads when it landed a de novo in 2018 for its ECG reading, which first went live on the Apple Watch Series 4. This kicked off a slew of other consumer wearable companies turning to the ECG space. In January, Withings announced its ScanWatch, which included ECG and Sp02 sensor capabilities. In August, Fitbit unveiled a slew of new wearables that also included an ECG feature.
However, before the Apple Watch 4, AliveCor had the KardiaBand, an FDA-cleared ECG wristband designed for the use with Apple Watches. However, in 2019 the company ended the sales of its technology. At the time the company said it decided to focus on the KardiaMobile 6L instead.
ON THE RECORD
"Kardia AI V2 is the most sophisticated AI ever brought to personal ECG," AliveCor CEO Priya Abani, said in a statement. "This suite of algorithms and visualizations will provide the platform for delivery of new consumer and professional service offerings beyond AFib, by allowing a much wider range of cardiac conditions to be determined on a personal ECG device."