Wednesday, June 26, 2024
AliveCor, the global leader in AI-powered cardiology, has announced the U.S. Food & Drug Administration (FDA) clearance and commercial launch of the KAI™ 12L AI technology and the Kardia™ 12L ECG System.
This groundbreaking AI is the first in the world capable of detecting life-threatening cardiac conditions, including heart attacks, using a reduced leadset.
The Kardia 12L ECG System, featuring patented technology, is the world's first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.
The KAI 12L technology employs multiple deep neural network algorithms, trained and validated on over 1.75 million ECGs from leading U.S. medical centers.
This AI can detect 35 cardiac conditions, including 14 arrhythmias and 21 morphologies, such as acute myocardial infarction (MI) and common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, enhancing access to accurate heart data across various healthcare settings.
"Not only is it the first FDA-cleared AI capable of detecting a heart attack with a reduced leadset, but it also returns determinations for our broadest range of conditions yet."
"When paired with our pocket-sized Kardia 12L ECG System, this technology is poised to revolutionize traditional care pathways and represents a significant advancement in cardiac care."
The Kardia 12L ECG System is an innovative solution requiring only a single cable with five electrodes to acquire eight high-quality diagnostic bandwidth leads. Conventional 12-lead ECG machines, the standard for detecting and diagnosing many heart conditions, are often limited by their size and complexity.
The Kardia 12L, using advanced KAI 12L technology and a reduced leadset, offers clinical efficiency and performance comparable to state-of-the-art ECG analysis solutions. Its speed and simplicity assist healthcare providers in rapid disease detection and improve the patient experience.
"The AI innovations in the Kardia 12L ECG System offer healthcare providers a clinically validated handheld 12-lead ECG system, expanding this critical technology into more resource-limited settings."
"By streamlining the process of recording a 12-lead ECG, the Kardia 12L has significant implications for rapid ECG diagnosis in clinical practice."
The Kardia 12L is battery-operated, weighs just 0.3 pounds, and fits in a pocket, making it significantly smaller, more portable, and more convenient than conventional 12-lead ECG machines. Its streamlined leadset is 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 make 12-lead ECG data accessible to more healthcare providers in various healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and under-resourced or rural venues.
Source: prnewswire.com
