The Kardia 12L, which uses five electrodes and a single cable to replace bulky 10-lead ECG carts, received the CE mark. It is first launched in France, Germany, Italy, Spain and the United Kingdom, and its artificial intelligence system detects 35 heart conditions, including acute myocardial infarction.
AliveCorThe American medical technology company specializing in cardiac diagnostics based on artificial intelligence, received the CE mark for its Kardia 12L ECG system, allowing it to launch it in Europe.
The device, described by the company as the world’s first AI-powered 12-lead wearable ECG with a unique single-lead design, will be available first to healthcare professionals in France, Germany, Italy, Spain and the United Kingdom, with other European countries to follow. The CE mark allows distribution throughout the European Economic Area.
The Kardia 12L replaces the conventional 10-electrode ECG cart with a five-electrode single-lead system that weighs just 0.13 kg. Its AI engine, KAI 12L, detects 35 cardiac determinations in the CE-marked version, including 14 arrhythmias and 21 morphologies, including acute myocardial infarction and the most common types of cardiac ischemia.
The device is battery-operated and pocket-sized, and is designed for use in primary care, urgent care, pharmacies, rural clinics, and home visits by healthcare professionals – settings where traditional ECG carts are not practical due to the size and complexity of the setup.
Its five-electrode configuration also means that patients do not need to completely undress during a reading. A peer-reviewed study published in Heart Rhythm O2 found a nearly 30% reduction in ECG acquisition time compared to standard 12-lead configurations.
Since its FDA approval and commercial launch in the US in June 2024, Kardia 12L has been adopted across the US and subsequently expanded to India, Australia, New Zealand, Vietnam and Canada.
The system has been used in tens of thousands of patients worldwide and has identified more than 4,000 cases of myocardial infarction and ischemia, a figure that AliveCor cites to demonstrate clinical utility at scale.
KAI 12L, the underlying AI, was trained and validated on more than 1.75 million ECGs from major US medical centers. In January 2026, the FDA cleared an expanded version of KAI 12L that detects 39 cardiac measurements; The CE-marked version launches with 35, and the specific determination set varies by geography as regulatory approvals are obtained.
The European launch comes as the EU Cardiovascular Health Plan reinforces the bloc’s commitment to early detection and improving access to care for cardiovascular diseases, the leading cause of mortality across Europe.
Simona Esposito, senior vice president of sales for global markets at AliveCor, described the CE mark as “a decisive moment” in the company’s global strategy, noting that the device was designed specifically for environments where traditional ECG carts are not practical.
AliveCor is a privately held company based in Mountain View, California; has recorded over 350 million ECGs across its Kardia range of devices.
