AliveCor Announces Dual FDA Clearance of AI Technology That Delivers… (2024)

World’s First AI to Detect 35 Cardiac Determinations, Including Heart Attack, Using a Reduced Leadset

Powered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions


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 healthcare providers interested in purchasing a Kardia 12L, please visit alivecor.com/products/kardia12L.

About AliveCor

AliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L to detect 35 cardiac conditions (14 arrhythmias and 21 morphologies), was designed exclusively for use by healthcare providers. AliveCor's enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook.

Media Contacts

Su Lee
slee191@alivecor.com
(562) 544-4634

Ben Rickles
Ben.Rickles@mboothhealth.com
(404) 502-6766

AliveCor Announces Dual FDA Clearance of AI Technology That Delivers… (2024)

FAQs

AliveCor Announces Dual FDA Clearance of AI Technology That Delivers…? ›

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

Is AliveCor FDA approved? ›

AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for healthcare professionals to use the KardiaMobile 6L device to calculate patients' QTc interval.

Where is AliveCor located? ›

AliveCor is a privately-held company headquartered in Mountain View, Calif.

What is the Apple issue with AliveCor? ›

AliveCor filed its case in the U.S. District Court for the Western District of Texas, claiming that Apple had infringed on three of its patents — all of which focus on monitoring cardiac arrhythmia. These patents covered AliveCor's technology and methods for detecting and analyzing heart rhythms using portable devices.

Do cardiologists recommend KardiaMobile? ›

With its advanced detection capabilities and user-friendly design, KardiaMobile 6L is the ultimate heart health monitoring device for those who want to stay ahead of their heart health. In general, the KardiaMobile 6L is my most recommended device to my patients.

What is the AliveCor vs Apple lawsuit? ›

U.S. District Judge Jeffrey White in Oakland, California, ruled on Tuesday against AliveCor, which had developed an app for detecting irregular heartbeats. It accused Apple of violating the federal Sherman antitrust law and a California unfair competition law.

Does AliveCor have a monthly fee? ›

Once you subscribe to KardiaCare or Premium, $11.99 USD, or the local price, will be charged to the credit card used on a recurring monthly basis. The date of the charge will be on the day you sign up for your subscription. For example, if you sign up on March 31, your charge will recur on the last day of every month.

Is Kardia a real EKG? ›

Our Kardia devices are the most clinically validated personal EKGs in the world, providing accurate EKG results and a wider range of arrhythmia detections than any other smart device.

What ECG app is FDA-approved? ›

“The ECG App is Garmin's first FDA-cleared smartwatch feature and we are thrilled to offer this revolutionary tool to our customers as another way to stay on top of their health,” said Dan Bartel, Garmin vice president of global consumer sales.

How can you tell if a device is FDA-approved? ›

Check for Approved and Cleared Products in the Devices@FDA Database: Devices@FDA is a catalog of approved and cleared medical device information from the FDA. To search for FDA-approved or FDA-cleared products by device name or company name: Go to the Devices@FDA Database.

Is KardiaMobile really medical grade? ›

KardiaMobile is a smart device that can record a medical-grade electrocardiogram (EKG) right on your smartphone.

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