AliveCor Launches AI-Powered Kardia 12L ECG in Europe After CE Mark
The five-electrode, single-cable system arrives first in France, Germany, Italy, Spain and the UK with an AI engine that reports 35 cardiac determinations.
Key points
- AliveCor said it received CE Mark for the Kardia 12L ECG System and its KAI 12L AI, allowing distribution across the European Economic Area.
- The CE-marked version detects 35 cardiac determinations, 14 arrhythmias and 21 morphologies, while an expanded US version cleared in January covers 39, according to coverage of the launch.
- Kardia 12L will be available first to healthcare providers in France, Germany, Italy, Spain and the UK.
AliveCor said on April 15 that it has received CE Mark for its Kardia 12L electrocardiogram system and the KAI 12L artificial intelligence that interprets its readings, and that it will begin selling the handheld 12-lead ECG to healthcare providers in Europe, according to the company's press release.
The Mountain View, California, company said the system will be available first in France, Germany, Italy, Spain and the United Kingdom, with other European countries to follow. The CE Mark allows distribution across the European Economic Area.
What the device does
Kardia 12L uses a single cable and five electrodes in place of the 10 leads used with conventional ECG carts, according to AliveCor. The company said the device weighs 0.13 kilograms, runs on a battery and is intended for use by healthcare professionals in settings such as hospitals, primary and urgent care, pharmacies, rural clinics and home visits. It is not intended for home use by patients on their own.
The KAI 12L software detects 35 cardiac determinations in Europe, made up of 14 arrhythmias and 21 morphologies, including acute myocardial infarction and the most common types of cardiac ischemia, the company said. The Next Web reported that the AI was trained and validated on more than 1.75 million ECGs from US medical centers, and that the FDA cleared an expanded version detecting 39 determinations in January 2026, with the available set varying by geography.
AliveCor said research has shown nearly a 30% reduction in ECG acquisition time compared with standard 12-lead setups. The Next Web said that finding came from a peer-reviewed study in Heart Rhythm O2.
US track record and European push
Kardia 12L received FDA clearance and launched in the United States in June 2024, and has since been introduced in India, Australia, New Zealand, Vietnam and Canada, the company said. AliveCor said clinicians have used it on tens of thousands of patients and that it has identified more than 4,000 instances of MI and ischemia; The Next Web described that as a figure AliveCor cites to demonstrate clinical utility.
"Securing CE Mark for the Kardia 12L is a defining moment in our strategy to scale AliveCor's global footprint," said Simona Esposito, senior vice president of sales for global markets. She said the company's priority is getting the device to clinicians "especially in settings where traditional, bulky ECG carts simply aren't practical."
Alejandro Barbagelata, an adjunct assistant professor of medicine and cardiology at Duke University, said in the release that the device "offers a unique combination of portability and diagnostic depth, allowing HCPs to make informed care decisions."
AliveCor, which is privately held, did not disclose European pricing or distribution partners.