Sam Brusco, Associate Editor06.25.24
AliveCor has gained U.S. Food and Drug Administration (FDA) clearance for and commercially launched its KAI 12L artificial intelligence (AI) technology and the Kardia 12L ECG system.
According to the company, this is the world’s first AI that can spot life-threatening cardiac conditions, including heart attacks, using a reduced leadset. Kardia 12L ECG is also the world’s first AI-powered, handheld, 12-lead ECG system with a single-cable design.
Battery-operated and weighing in at 0.3 pounds, KAI 12L uses multiple deep neural network algorithms that were trained and validated on over 1.75 million ECGs from leading U.S. medical centers. The AI tech and reduced leadset can spot 35 cardiac determinations—14 arrhythmias and 21 morphologies—including myocardial infarction (MI) and the most common types of cardiac ischemia. It integrates with compatible devices, which includes the Kardia 12L ECG.
![](https://images.rodpub.com/images/308/999_main.jpg)
Patients don't need to fully disrobe during a reading. Photo: AliveCor.
Kardia 12L ECG needs merely a single cable with five electrodes to acquire eight high-quality diagnostic bandwidth leads, according to AliveCor. The company touts it as substantially equivalent to state-of-the-art ECG analysis solutions, with added speed and simplicity to help with rapid disease detection.
Patients don’t need to fully disrobe during a reading, either. AliveCor claims the device needs only minimal, self-guided training and is simpler to use than standard 12-lead ECG machines. The company hopes to put 12-lead ECG data in reach of primary and urgent care offices, employer clinics, and other under-resourced or rural venues.
"Not only is it the first FDA-cleared AI that can detect a heart attack on a reduced leadset, but it also returns determinations for our broadest range of conditions yet," said Priya Abani, CEO of AliveCor. "Paired with our pocket-sized Kardia 12L ECG System, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care."
Earlier this year, AliveCor began a collaboration to integrate its KardiaMobile 6L personal ECG with Delve Health’s LiveCare Link + smart RPM (remote patient monitoring) gateway.
According to the company, this is the world’s first AI that can spot life-threatening cardiac conditions, including heart attacks, using a reduced leadset. Kardia 12L ECG is also the world’s first AI-powered, handheld, 12-lead ECG system with a single-cable design.
Battery-operated and weighing in at 0.3 pounds, KAI 12L uses multiple deep neural network algorithms that were trained and validated on over 1.75 million ECGs from leading U.S. medical centers. The AI tech and reduced leadset can spot 35 cardiac determinations—14 arrhythmias and 21 morphologies—including myocardial infarction (MI) and the most common types of cardiac ischemia. It integrates with compatible devices, which includes the Kardia 12L ECG.
![](https://images.rodpub.com/images/308/999_main.jpg)
Patients don't need to fully disrobe during a reading. Photo: AliveCor.
Patients don’t need to fully disrobe during a reading, either. AliveCor claims the device needs only minimal, self-guided training and is simpler to use than standard 12-lead ECG machines. The company hopes to put 12-lead ECG data in reach of primary and urgent care offices, employer clinics, and other under-resourced or rural venues.
"Not only is it the first FDA-cleared AI that can detect a heart attack on a reduced leadset, but it also returns determinations for our broadest range of conditions yet," said Priya Abani, CEO of AliveCor. "Paired with our pocket-sized Kardia 12L ECG System, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care."
Earlier this year, AliveCor began a collaboration to integrate its KardiaMobile 6L personal ECG with Delve Health’s LiveCare Link + smart RPM (remote patient monitoring) gateway.