AliveCor has announced it has received CE Mark (Conformité Européenne) for the Kardia 12L electrocardiogram (ECG) System powered by KAI 12L AI technology. The company says the Kardia 12L is the world’s first AI-powered, portable 12-lead ECG system featuring a unique, single-cable design for Health Care Professionals (HCPs).
Powered by KAI 12L, the system enables faster, easier detection of 35 cardiac determinations, including acute myocardial infarction (MI) and the most common types of cardiac ischemia.
“Securing CE Mark for the Kardia 12L is a defining moment in our strategy to scale AliveCor’s global footprint,” said Simona Esposito, Senior Vice President 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.”
AliveCor says KAI 12L is the first AI of its kind to detect life-threatening cardiac conditions using a reduced leadset and can identify a comprehensive range of conditions. This includes 14 arrhythmias and 21 morphologies including serious conditions like acute MI and the most common types of cardiac ischemia.
The company says the device is specifically designed to expand access to accurate cardiac data across diverse healthcare and acute settings, the system allows for the rapid identification of life-threatening conditions like heart attack.
The device weighs just 0.13 kg (0.3 lbs) and is battery-operated, allowing it to be used by HCPs in primary care, urgent care, pharmacy, the home and rural clinics where traditional ECG machines may be impractical due to their size and complexity.
According to AliveCor, the simplified five-electrode setup makes it less invasive for patients, who do not need to fully disrobe during a reading, and typically allows for faster acquisition. Research has shown nearly a 30% reduction in ECG acquisition time compared to standard 12-lead setups.
“In a fast-paced clinical environment, every second counts, but we cannot sacrifice accuracy for speed,” said Dr. Alejandro Barbagelata, Adjunct Assistant Professor of Medicine and Cardiology at Duke University. “Kardia 12L offers a unique combination of portability and diagnostic depth, allowing HCPs to make informed care decisions. By streamlining the acquisition process, it enables clinicians to identify life-threatening conditions like MI much faster, leading to better patient outcomes across the board.”
Since its FDA clearance and subsequent launch in the United States in June 2024, Kardia 12L has seen growing global adoption including in India, Australia, New Zealand, Vietnam and Canada says the company. The system has been adopted by clinicians across the globe capturing critical heart data on tens of thousands of patients. AliveCor says the system has identified over 4,000 instances of MI and ischemia.
The company says this launch comes at a pivotal time, as the European Union reinforces its commitment to tackling cardiovascular diseases, the leading cause of mortality in Europe, through its EU Cardiovascular Health Plan, which prioritises early detection, prevention, and improved access to care.
Kardia 12L will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, and will be followed by additional European countries soon.
