AliveCor has received CE Mark for its Kardia 12L electrocardiogram system, clearing the device for distribution across the European Economic Area.
The handheld, battery-operated system uses a unique single-cable, five-electrode design to produce a 12-lead ECG at the point of care and is powered by KAI 12L AI that the company says detects 35 cardiac determinations, including acute myocardial infarction and common types of cardiac ischemia.
Weighing 0.13 kg, the device is intended for use by healthcare professionals in settings such as primary care, urgent care, pharmacies, home visits by clinicians, rural clinics and hospitals, with the company noting minimal self-guided training is required for clinicians.
Research cited by the company indicates a nearly 30 percent reduction in ECG acquisition time compared with standard 12-lead setups, and the company claims global adoption across multiple countries, with more than 4,000 instances of myocardial infarction and ischemia captured to date.
Kardia 12L will be available first to providers in France, Germany, Italy, Spain and the United Kingdom, according to the company, with wider European rollout to follow.
