June 25, 2024 — AliveCoa global leader in AI-enabled cardiology, today announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of its KAI 12L AI Technology and Kardia 12L ECG System, the world’s first AI that can detect life-threatening cardiac conditions such as heart attack using a reduced lead set. Featuring innovative patented technology, the Kardia 12L ECG System is the world’s first AI-enabled handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.
KAI 12L employs multiple deep neural network algorithms that have been trained and validated on over 1.75 million ECGs from leading U.S. medical centers. Using a reduced lead set, this AI technology can detect 35 cardiac events (14 types of arrhythmias and 21 morphologies), including critical conditions such as acute myocardial infarction (MI) and the most common type of cardiac ischemia. KAI 12L seamlessly integrates with compatible devices such as the Kardia 12L ECG System, expanding critical access to accurate cardiac data across a wide range of clinical settings.
“Not only is this the first FDA-approved AI that can detect heart attacks with a reduced lead set, it also returns the broadest range of symptom outcomes to date,” said Priya Abani, CEO of AliveCor. “Paired with our pocket-sized Kardia 12L ECG system, this product will disrupt traditional care pathways and represent a breakthrough in cardiac care.”
The Kardia 12L ECG system is an innovative solution that allows you to obtain eight high-quality diagnostic bandwidth leads with only one cable with five electrodes. Traditional 12-lead ECG equipment is the standard of care for detecting and diagnosing many cardiac diseases, but their size and complexity can limit utilization. With the advanced KAI 12L and reduced lead set, the Kardia 12L offers superior clinical efficiency and performance virtually equivalent to state-of-the-art ECG analysis solutions. Its speed and simplicity enable healthcare professionals to detect disease faster and improve patient experience.
“The AI innovation in the Kardia 12L ECG system provides healthcare professionals with a clinically validated, handheld 12-lead ECG system, expanding this important technology to more resource-limited settings,” said Stavros Stavrakis, M.D., professor in the Department of Cardiology, College of Medicine, University of Oklahoma Health Sciences Center. “By streamlining the 12-lead ECG recording process, Kardia 12L will have a significant impact on rapid ECG diagnosis at the clinical point of care.”
The Kardia 12L is battery-powered, weighs just 0.3 pounds, and fits in your pocket, making it significantly smaller, more portable, and more convenient than traditional 12-lead ECG devices. It is also less invasive to patients with its streamlined lead set, which does not require complete doffing during readings. The device requires minimal self-directed training and is easier to use than standard 12-lead ECG devices. These features make 12-lead ECG data more available to more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employers’ clinics, and other under-resourced or rural facilities.
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