Summary: AliveCor has launched the FDA-cleared KAI 12L AI technology and the Kardia 12L ECG System, offering advanced, portable, and user-friendly cardiac care solutions for a broad range of healthcare settings.

Key Takeaways:

  • KAI 12L AI technology can detect 35 cardiac conditions using a reduced leadset, including serious conditions like heart attacks, and integrates seamlessly with the Kardia 12L ECG System.
  • The Kardia 12L ECG System is highly portable, easy to use, and designed to enhance patient experience while expanding access to 12-lead ECG data in various healthcare settings.

AliveCor announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of KAI 12L AI technology and the Kardia 12L ECG System. The AI can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System is an AI-powered, handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.

Advanced AI Technology

KAI 12L employs multiple deep neural network algorithms, trained and validated on more than 1.75 million ECGs from leading US medical centers. This AI technology can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, expanding critical access to accurate heart data within a broad range of healthcare settings.

“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.”

Innovative ECG System

The Kardia 12L ECG System requires only a single cable with 5 electrodes to acquire 8 high quality diagnostic bandwidth leads. Using advanced KAI 12L and a reduced leadset, Kardia 12L offers clinical efficiency and performance equivalent to modern ECG analysis solutions, according to the company. Its speed and simplicity also assist healthcare providers in rapid disease detection and enhancing patient experience.

Portability and Ease of Use

Kardia 12L is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it smaller and more portable than conventional 12-lead ECG machines. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler to use than standard 12-lead ECG machines. These features are designed to put 12-lead ECG data within reach of more healthcare providers in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues.