The Kardia 12L, which uses five electrodes and a single cable to replace bulky 10-lead ECG carts, has received CE Mark. It launches first in France, Germany, Italy, Spain, and the UK, with its AI system detecting 35 cardiac conditions including acute myocardial infarction.
AliveCor, the US medtech company specialising in AI-powered cardiac diagnostics, has received CE Mark for its Kardia 12L ECG system, enabling it to launch in Europe.
The device, described by the company as the world’s first AI-powered, portable 12-lead ECG with a unique single-cabledesign,will be available first to healthcare professionals in France, Germany, Italy, Spain, and the United Kingdom, with additional European countries to follow. CE Mark allows distribution across the entire European Economic Area.
The Kardia 12L replaces the conventional 10-electrode ECG cart with a five-electrode, single-cable system weighing just 0.13 kg. Its AI engine, KAI 12L, detects 35 cardiac determinations in the CE-marked version, including 14 arrhythmias and 21 morphologies, among them acute myocardial infarction and the most common types of cardiac ischaemia.
The device is battery-operated and pocket-sized, designed for use in primary care, urgent care, pharmacies, rural clinics, and home visits by healthcare professionals, environments where traditional ECG carts are impractical due to size and setup complexity.
Its five-electrode setup also means patients do not need to fully disrobe 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 setups.
Since its FDA clearance and US commercial launch 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 on tens of thousands of patients globally and has identified more than 4,000 instances of myocardial infarction and ischaemia, a figure 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 leading US medical centres. In January 2026, the FDA cleared an expanded version of KAI 12L detecting 39 cardiac determinations; the CE-marked version launches with 35, with the specific determination set varying by geography as regulatory approvals are obtained.
The European launch arrives as the EU Cardiovascular Health Plan reinforces the bloc’s commitment to early detection and improved access to care for cardiovascular disease, the leading cause of mortality across Europe.
Simona Esposito, AliveCor’s Senior Vice President of Sales for Global Markets, described the CE Mark as “a defining moment” in the company’s global strategy, noting that the device was specifically designed for settings where traditional ECG carts are impractical.
AliveCor is a privately held company headquartered in Mountain View, California; it has recorded more than 350 million ECGs through its Kardia devicerange.
