AliveCor, a Mountain View, California-based cardiology solutions company, has gained FDA clearance for its new line of AI-powered electrocardiogram (ECG) offerings.
The clearance includes algorithms capable of identifying key findings in a 30-second ECG. One algorithm was trained to detect if two or more ventricular ectopic beats are present, for instance, while another can alert the user when there is a QRS interval of 120 milliseconds or longer.
Users take these readings with AliveCor’s KardiaMobile and KardiaMobile 6L solutions and the company’s Kardia smartphone app. These products have already been used to detect normal sinus rhythm, atrial fibrillation (AFib), bradycardia and tachycardia.
“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,” Priya Abani, AliveCor CEO, said in a prepared statement.
According to AliveCor, this latest clearance means that the company can now “deliver AI-based remote cardiological services for the vast majority of cases when cardiac patients are not in front of their doctor.”
The newly-cleared algorithms are expected to hit the U.S. market in 2021.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.