AliveCor brings portable 12-lead ECG system to Europe with AI analysis
AliveCor received CE mark approval for Kardia 12L, a portable AI-powered 12-lead ECG system designed for use by healthcare professionals. The device uses the company's KAI 12L artificial intelligence to detect 35 cardiac conditions, including acute myocardial infarction and cardiac ischaemia, at the point of care.
The system features a single-cable design and provides ECG measurements comparable to standard 12-lead machines. Unlike traditional ECG carts, Kardia 12L prioritizes portability without sacrificing diagnostic depth.
What it detects
Kardia 12L identifies 14 types of arrhythmias and 21 morphologies. The system acquired ECG data on tens of thousands of patients since its US FDA clearance in June 2024, identifying over 4,000 cases of myocardial infarction and ischaemia.
Availability and adoption
The device will first roll out in France, Germany, Italy, Spain, and the UK, with additional European countries to follow. AliveCor has already deployed Kardia 12L in India, Australia, New Zealand, Vietnam, and Canada.
Simona Esposito, senior vice president of sales for global markets at AliveCor, said the CE mark approval allows the company to scale its presence in Europe. "Our priority is to get this lifesaving technology into the hands of as many clinicians as possible, especially in settings where traditional, bulky ECG carts simply aren't practical," she said.
Clinical context
Alejandro Barbagelata, a cardiologist at Duke University, said rapid ECG acquisition matters in acute care. "In a fast-paced clinical environment, every second counts, but we cannot sacrifice accuracy for speed," he said. "Kardia 12L offers a unique combination of portability and diagnostic depth, allowing healthcare professionals to make informed care decisions."
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