AliveCor’s Kardia 12L is now CE marked
By Ana-Maria Stanciuc
Published on April 15, 2026.
US medtech company, AliveCor, has received CE Mark for its Kardia 12L ECG system, which replaces bulky 10-lead ECG carts with a five-electrode, single-cabled system. The device will be available to healthcare professionals in France, Germany, Italy, Spain, and the UK, with additional European countries to follow. The system uses five electrodes and a single cable to detect 35 cardiac conditions, including acute myocardial infarction. Since its FDA clearance and US commercial launch in June 2024, the system has been adopted across the US and expanded to India, Australia, New Zealand, Vietnam, and Canada.
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