KAI 12L, the AI powering the Kardia 12L ECG system, can now detect five additional cardiac determinations with the clearance. That brings the total for the 12-lead electrocardiogram (ECG) technology to 39 cleared determinations.
Mountain View, California–based AliveCor develops the first-of-its-kind handheld ECG system to detect various cardiac conditions. It leverages the KAI 12L deep neural network machine learning AI model, an advanced AI software algorithm trained on more than 1 million recorded ECGs. Its nearly 40 determinations include myocardial infarction (heart attack) and the most common types of cardiac ischemia.
The battery-operated, pocket-sized system weighs just 0.3 lbs and uses just one cable with a reduced lead set. It features just five electrodes, halving the standard 10 electrodes, used to acquire eight high-quality diagnostic bandwidth leads. The company says this simplifies and speeds up the process of obtaining a reading, enabling physicians in rapid disease detection.
AliveCor won FDA clearance for the 12-lead ECG system midway through 2024. About a year ago, the company also picked up a significant reimbursement win for the technology.
The company said its latest FDA nod further enhances the diagnostic breadth of the AI-powered ECG, adding three additional rhythm modifiers to its capabilities. Those include short PR interval (short PR), atrial bigeminy, and ventricular bigeminy. It also now offers two axis-related morphology determinations: left axis deviation (LAD) and right axis deviation (RAD).
“We are continuously expanding the diagnostic capabilities of our AI, and this latest clearance puts even more power into the hands of clinicians, delivering a high-fidelity 12-lead ECG, whose portable form can be deployed in any location, even in the most restricted or unconventional care settings,” said Priya Abani, CEO of AliveCor. “This milestone further solidifies AliveCor’s leadership in AI-powered cardiology as we continue to disrupt traditional care pathways and drive greater efficiency for healthcare providers.”
