AliveCor has announced it has received a CE mark for the Kardia 12L electrocardiogram (ECG) system powered by the company’s KAI 12L artificial intelligence (AI) technology. Kardia 12L is described by the company as the “world’s first” AI-powered, portable 12-lead ECG system featuring a unique, single-cable design intended for healthcare professionals.
A press release from AliveCor also notes that the system enables faster, easier detection of 35 cardiac determinations, including acute myocardial infarction (MI) and the most common types of cardiac ischaemia.
“In a fast-paced clinical environment, every second counts, but we cannot sacrifice accuracy for speed,” commented Alejandro Barbagelata (Duke University, Durham, USA). “Kardia 12L offers a unique combination of portability and diagnostic depth, allowing healthcare professionals 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.”
Kardia 12L is a portable, AI-guided, 12-lead ECG solution capable of providing measurements and ECG interpretation that are “highly similar” to standard 12-lead ECG solutions, “right at the point of care”, enabling rapid acquisition of complete ECG information and offering a better patient experience, according to AliveCor.
In addition to its 35 cardiac determinations—including 14 arrhythmias and 21 morphologies—standout features of Kardia 12L outlined in the company’s recent release include rapid detection, operational efficiency, and improved patient and clinician experiences.
“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 for global markets at AliveCor. “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. 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.”
Since its US Food and Drug Administration (FDA) clearance and subsequent launch in the USA in June 2024, Kardia 12L has seen growing global adoption across geographies including India, Australia, New Zealand, Vietnam and Canada, AliveCor states. The system has been adopted by clinicians worldwide, capturing critical heart data on tens of thousands of patients, and has identified more than 4,000 instances of MI and ischaemia to date, the release adds.
Kardia 12L will first become available for healthcare providers in France, Germany, Italy, Spain, and the UK, later followed by additional European countries.
