US-based medical device company AliveCor has received the US Food and Drug Administration (FDA) approval for its KAI 12L AI technology and the Kardia 12L ECG System.
KAI 12L is designed to leverage multiple deep neural network algorithms, which are trained, and validated on more than 1.75 million electrocardiograms, from several US medical centres.
The AI technology can detect 35 cardiac determinations, 14 arrhythmias and 21 morphologies, including acute myocardial infarction (MI) and cardiac ischemia, using a reduced leadset.
It can easily integrate with compatible devices, such as the Kardia 12L ECG System, expanding critical access to accurate heart data within the range of healthcare settings.
AliveCor said that the Kardia 12L ECG System is the world’s first AI device that can detect deadly cardiac conditions, including heart attacks using a reduced leadset.
Also, it is the world’s first AI-powered, handheld 12-lead ECG system with a unique single-cable design, and leverages its patented technology, said the medical device company.
AliveCor CEO Priya Abani said: “Not only is it the first FDA-cleared AI that can detect a heart attack on a reduced leadset, but it also returns determinations for our broadest range of conditions yet.
“Paired with our pocket-sized Kardia 12L ECG System, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care.”
Kardia 12L is battery operated ECG System designed to weigh 0.3 pounds, a more compact, portable, and convenient option than conventional 12-lead ECG machines.
It requires only a single cable with five electrodes to acquire 8 high-quality diagnostic bandwidth leads and is less invasive for patients, who do not need to fully disrobe during a reading.
AliveCor said that the availability of conventional 12-lead ECG machines, the standard of care for diagnosing many heart conditions, is limited due to their size and complexity.
The KAI 12L technology and its reduced leadset allow Kardia 12L to provide superior clinical efficiency and performance equivalent to advanced ECG analysis solutions.
Furthermore, the device’s speed and simplicity help healthcare providers rapidly detect diseases and improve patient experience, said the medical device company.
