AliveCor announced that it received CE mark for its Kardia 12L electrocardiogram (ECG) system.
Mountain View, California-based AliveCor describes it as the world’s first AI-powered, portable 12-lead ECG system featuring a unique, single-cable design for healthcare professionals.
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Powered by AI, the system enables faster, easier detection of 35 cardiac determinations. Those include acute myocardial infarction (MI) and the most common types of cardiac ischemia. It leverages the KAI 12L deep neural network machine learning AI model, an advanced AI software algorithm trained on more than 1 million recorded ECGs.
The battery-operated, pocket-sized system weighs just 0.3 lbs and uses just one cable with a reduced lead set. It features just five electrodes, halving the standard 10 electrodes, used to acquire eight high-quality diagnostic bandwidth leads. The company says this simplifies and speeds up the process of obtaining a reading, enabling physicians in rapid disease detection.
Since its 2024 FDA clearance, Kardia 12L also expanded across India, Australia, New Zealand, Vietnam and Canada. Now, with more than 4,000 instances of MI and ischemia already identified, it goes to Europe.
AliveCor plans to begin its European launch for Kardia 12L in France, Germany, Italy, Spain and the UK. It expects additional European countries to follow.
“Securing CE Mark for the Kardia 12L is a defining moment in our strategy to scale AliveCor’s global footprint,” said Simona Esposito, SVP of sales, global markets at AliveCor. “Our priority is to get this life-saving technology into the hands of as many clinicians as possible, especially in settings where traditional, bulky ECG carts simply aren’t practical. By simplifying the hardware without sacrificing diagnostic depth, we are fundamentally improving access to high-quality cardiac care and reducing the burden of cardiovascular disease in the EU.”
