Mountain View, California–based AliveCor’s first-of-its-kind handheld ECG system leverages a deep neural network machine learning AI model called KAI 12L AI. This advanced AI software algorithm—trained on more than 1 million recorded ECGs—can detect 35 different conditions. Among those are myocardial infarction (otherwise known as a heart attack) and the most common types of cardiac ischemia.
Kardia 12L, a 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.
The FDA cleared the AliveCor 12-lead ECG system midway through last year.
CMS assigned the AI-powered technology to Ambulatory Payment Classification (APC) 5733. This enable hospital outpatient settings to receive a Medicare payment rate of $59.40 when using the system to perform ECGs.
“Cardiovascular disease remains the leading cause of death in the U.S., and CMS’s decision to set a Medicare payment rate for the AI-powered ECG represents a major step toward broadening access to this potentially life-saving heart health technology,” said Sanjay Voleti, chief business officer at AliveCor. “By leveraging advanced AI to diagnose more conditions than ever, the reliable and easy-to-use Kardia 12L ECG System sets a new standard in cardiac care, democratizing access to critical heart data and highlighting the value of widespread ECG use in clinical practice.”
This CMS win follows Abbott’s Medicare win for CardioMEMS, a separate type of cardiac monitoring system, earlier this week.
