FDA Clears Five More Cardiac Findings for AliveCor's Kardia 12L AI
The next generation of KAI 12L adds short PR interval, atrial and ventricular bigeminy and two axis deviations, bringing the handheld 12-lead ECG's cleared determinations to 39, the company said.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- AliveCor said on January 13 that the FDA has cleared the next generation of KAI 12L, the AI software behind its Kardia 12L ECG system, for five additional cardiac determinations.
- The additions are three rhythm modifiers (short PR interval, atrial bigeminy, ventricular bigeminy) and two morphology determinations (left and right axis deviation), for a total of 39.
- The company said Kardia 12L, launched in June 2024, is used by more than 250 practices; its release did not give a 510(k) number.
AliveCor said on January 13 that the U.S. Food and Drug Administration has cleared the next generation of KAI 12L, the artificial intelligence software that interprets readings from its handheld Kardia 12L electrocardiogram (ECG) system, to detect five additional cardiac determinations, bringing the total cleared to 39, according to the company's announcement.
The new determinations are three rhythm modifiers, short PR interval, atrial bigeminy and ventricular bigeminy, and two axis-related morphology determinations, left axis deviation and right axis deviation. The Mountain View, California, company did not give a 510(k) number or decision date in its release.
What the system does
Kardia 12L uses a single cable and five electrodes to acquire eight diagnostic-bandwidth leads, from which KAI 12L produces its interpretations, the company said. AliveCor describes the device as battery-operated and weighing 0.3 pounds, and says patients do not need to fully undress for a reading, unlike with conventional 12-lead machines.
The company calls Kardia 12L the world's first AI-powered handheld 12-lead ECG system with a single-cable design; that description is AliveCor's own.
“We are continuously expanding the diagnostic capabilities of our AI, and this latest clearance puts even more power into the hands of clinicians,” said Priya Abani, AliveCor's chief executive, in the release. She said the milestone “further solidifies AliveCor's leadership in AI-powered cardiology.”
Adoption and payment
Since its U.S. launch in June 2024, Kardia 12L has been adopted by more than 250 practices and has expanded into India, Australia and New Zealand, with European regulatory reviews under way, AliveCor said. The company also said the system has identified more than 4,000 instances of myocardial infarction and ischemia; that figure is company-reported.
AliveCor said the Centers for Medicare & Medicaid Services approved Medicare payment for Kardia 12L in hospital outpatient settings in 2025, following the American Medical Association's assignment of Category III CPT codes in 2024.
The company cites a peer-reviewed study in Heart Rhythm O2 that found Kardia 12L cut ECG acquisition time by 29%. As HCPLive reported, that study gave 50 patients at the electrophysiology clinic of Northwestern Memorial Hospital a Kardia 12L ECG in place of a standard 12-lead ECG. Median acquisition took 7.1 minutes with Kardia 12L against 10 minutes for the standard ECG, and five patients needed an additional standard ECG, two because of poor signal quality and three because the QT interval could not be measured definitively due to printer settings, according to the report.
Kardia 12L is sold to health care providers. AliveCor, which is privately held, also makes FDA-cleared personal ECG devices, the company said.
Sources
- AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39, AliveCor, January 13, 2026
- FDA Clears AI Program Powering Kardia 12L Electrogram for 5 New Cardiac Determinations, HCPLive, January 13, 2026