AliveCor has announced the launch of its Kardia 12L electrocardiogram (ECG) system in India. The company stated that the device is the world’s first AI-powered, handheld 12-lead ECG system with a single-cable design. It is designed for use by healthcare professionals and has received approval from the Central Drugs Standard Control Organisation (CDSCO).
According to AliveCor, Kardia 12L can detect 35 cardiac determinations, including 14 arrhythmias and 21 morphologies. These include conditions such as acute myocardial infarction (MI) and the most common types of cardiac ischemia.
“Kardia 12L enables physicians to rapidly detect heart diseases across a wide range of healthcare settings, making this critical medical device more accessible than ever before,” said Priya Abani, CEO of AliveCor. “More importantly, the launch of the Kardia 12L ECG system in India marks a big win for physicians and patients in the country, at a time when the healthcare system has never been more constrained, or more in need of the access and efficiency this type of solution provides.”
Estimates suggest that India is projected to suffer an economic loss of approximately $2.17 trillion due to cardiovascular diseases (CVD) between 2012 and 2030. AliveCor noted that while conventional 12-lead ECG machines are considered effective, they are limited by their size and complexity, often confining them to hospital settings.
“AliveCor’s Kardia 12L ECG System was born from our vision to leverage AI and revolutionize traditional ECG screening,” said Dr. David E. Albert, Founder and Chief Medical Officer of AliveCor. “We have compelling clinical evidence that our AI, paired with our device’s reduced leadset, delivers results on par with the gold-standard ECG that are typically only available in hospital settings, democratizing access to potentially life-saving heart data.”
The Kardia 12L system was first launched in the United States, where AliveCor reported clinical acceptance. The company said the device supports clinicians in rapid disease detection and assists in improving patient experience.
“The launch of Kardia 12L marks a new era in cardiac diagnostics. In a country facing a rising burden of heart disease, this innovation reflects the future of healthcare—one that is portable, powerful, and built to empower clinicians at the point of care,” said Anuj Seth, Managing Director of AliveCor India Pvt. Ltd. “This groundbreaking achievement underscores our unwavering commitment to providing medical-grade cardiac diagnostic capabilities to every patient in need, improving access to medical-grade care.”
AliveCor stated that the Kardia 12L weighs 135 grams, is battery-operated, and fits in a physician’s lab coat pocket. The company added that the device requires minimal training, is simpler to use than conventional machines, and reduces the need for patients to fully disrobe during a reading due to its streamlined leadset.