One-cable design + AI trained with one million ECGs.
The FDA-cleared Kardia 12L is an AI-powered handheld 12-lead resting ECG system. With simplified leadset technology, Kardia 12L offers outstanding clinical efficiency that expands access to 12-lead recordings in more settings than ever before.
Its unique single-cable design makes lead placement more intuitive and less error-prone, so even qualified personnel with infrequent ECG experience can acquire an accurate recording in minutes.
And with 1 million ECGs from leading U.S. medical institutions, our team developed a robust algorithm with multiple deep neural network AI models. The Kardia 12L ECG algorithm received FDA 510(k) clearance by demonstrating substantial equivalence to the state-of-the-art 12-lead ECG algorithm.
See the 35 FDA-cleared determinations it can detect.