The Kardia 12L, which uses five electrodes and a single cable to replace bulky 10-lead ECG carts, has received the CE mark. It is first launched in France, Germany, Italy, Spain and the UK with an AI system that detects 35 heart conditions, including acute myocardial infarction.
AliveCorUS medtech company Kardia, which specializes in artificial intelligence-powered cardiac diagnostics, has received CE Mark for its Kardia 12L ECG system, allowing it to be launched in Europe.
Described by the company as the world’s first artificial intelligence-powered, portable 12-lead ECG with a unique single-lead design, the device will initially be available to healthcare professionals in France, Germany, Italy, Spain and the UK, with additional European countries. The CE Mark allows distribution throughout the European Economic Area.
Kardia 12L replaces the conventional 10-electrode ECG cart with a five-electrode, single-lead system weighing only 0.13 kg. Its AI engine, KAI 12L, in the CE-marked version, detects 35 heart conditions, including 14 arrhythmias and 21 morphologies, including the most common types of acute myocardial infarction and cardiac ischemia.
The device is battery-operated and pocket-sized, designed for use in primary care, emergency rooms, pharmacies, rural clinics and home visits by medical professionals, in environments where traditional ECG carts are impractical due to size and installation complexity.
Its five-electrode design also means patients don’t need to completely undress while reading. An expert study published in Heart Rhythm O2 found a nearly 30% reduction in ECG acquisition time compared to standard 12-lead devices.
Since FDA clearance and commercial launch in the US in June 2024, Kardia 12L has been accepted in the US and later expanded to India, Australia, New Zealand, Vietnam and Canada.
The system has been used on tens of thousands of patients globally and identified more than 4,000 cases of myocardial infarction and ischemia, citing AliveCor to demonstrate clinical benefit at scale.
KAI 12L, the main artificial intelligence, has been trained and validated on more than 1.75 million ECGs from leading US medical centers. In January 2026, the FDA cleared an expanded version of the KAI 12L, which detects 39 cardiac parameters; The CE-marked version starts with the 35, with a set of special designations that vary by geography as regulatory approvals are received.
The European launch comes as the EU’s Cardiovascular Health Plan reinforces the bloc’s commitment to improving early detection and access to care for cardiovascular disease, Europe’s leading cause of death.
Simona Esposito, AliveCor’s Senior Vice President of Global Markets Sales, described the CE mark. “defining moment” in the company’s global strategy, noting that the device is specifically designed for settings where traditional ECG carts are impossible.
AliveCor is a privately held company headquartered in Mountain View, California; it has recorded more than 350 million ECGs through its Kardia range of devices.
