News | Artificial Intelligence | June 25, 2024

AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

World’s first AI to detect 35 cardiac determinations, including heart attack, using a reduced leadset

Pocket-Sized Kardia 12L ECG System

Pocket-Sized Kardia 12L ECG System


June 25, 2024 — AliveCor, the global leader in AI-powered cardiology, today announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of KAI 12L AI technology and the Kardia 12L ECG System. This is the world’s first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world’s first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design. 

KAI 12L employs multiple deep neural network algorithms, trained and validated on more than 1.75 million ECGs from leading US medical centers. This AI technology can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, expanding critical access to accurate heart data within a broad range of healthcare settings.

“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,” said Priya Abani, CEO of AliveCor. “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 ECG System is an innovative solution that requires only a single cable with 5 electrodes to acquire 8 high quality diagnostic bandwidth leads. Conventional 12-lead ECG machines are the standard of care for detecting and diagnosing many heart conditions, but their availability can be limited due to their size and complexity. Using advanced KAI 12L and a reduced leadset, Kardia 12L offers outstanding clinical efficiency and performance substantially equivalent to state-of-the-art ECG analysis solutions. Its speed and simplicity assists healthcare providers in rapid disease detection and enhancing patient experience.

“The AI innovations in the Kardia 12L ECG System offer healthcare providers a clinically-validated handheld 12-lead ECG system and expands this critical technology into more resource-limited settings,” said Dr. Stavros Stavrakis, MD, PhD, Professor of Medicine, Division of Cardiology at the University of Oklahoma Health Sciences Center. “By streamlining the process of recording a 12-lead ECG, Kardia 12L has significant implications for rapid ECG diagnosis in clinical practice.” 

Kardia 12L is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it significantly smaller, more portable and more convenient than conventional 12-lead ECG machines. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues. 

For more information: www.alivecor.com


Related Content

News | FDA

July 2, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott has issued a correction for its ...

Home July 02, 2024
Home
News | FDA

June 18, 2024 — Elixir Medical has announced the company’s novel bioadaptive implant, DynamX Sirolimus-Eluting Coronary ...

Home June 18, 2024
Home
News | FDA

June 17, 2024 — Elutia Inc., a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting ...

Home June 17, 2024
Home
News | FDA

June 13, 2024 — Xeltis, a leading developer of transformative implants that enable the natural creation of living and ...

Home June 13, 2024
Home
News | FDA

June 3, 2024 — Heuron, a specialized medical AI startup focused on brain and neurological disorders based in South Korea ...

Home June 03, 2024
Home
News | FDA

May 17, 2024 — Implicity, a leader in remote patient monitoring and cardiac data management solutions, announced it has ...

Home May 17, 2024
Home
News | FDA

May 15, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling the HeartMate 3 LVAS by ...

Home May 15, 2024
Home
News | FDA

May 8, 2024 — The US Food and Drug Administration (FDA) is alerting health care providers and facilities about our ...

Home May 08, 2024
Home
News | FDA

May 8, 2024 — 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally ...

Home May 08, 2024
Home
News | FDA

May 7, 2024 — RapidAI, the global leader in developing clinically deep Artificial Intelligence (AI) and technology ...

Home May 07, 2024
Home
Subscribe Now