Now CE Marked, the Kardia 12L ECG System leverages AI to detect 35 cardiac determinations, simplifying the ECG process and expediting access to critical heart data
AliveCor’s Kardia 12L launches in Europe

AliveCor Launches AI-Powered Kardia 12L in Europe: The World’s First Handheld 12-Lead ECG with a Unique Single-Cable Design

MOUNTAIN VIEW, Calif., April 15, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced it has received CE Mark (Conformité Européenne) for the Kardia™ 12L electrocardiogram (ECG) System powered by KAI™ 12L AI technology. Kardia 12L is the world’s first AI-powered, portable 12-lead ECG system featuring a unique, single-cable design for Health Care Professionals (HCPs). Powered by KAI 12L, the system enables faster, easier detection of 35 cardiac determinations, including acute myocardial infarction (MI) and the most common types of cardiac ischemia. “Securing CE Mark for the Kardia 12L is a defining moment in our strategy to scale AliveCor’s global footprint,” said Simona Esposito, Senior Vice President of Sales, Global Markets at AliveCor. “Our priority is to get this life-saving technology into the hands of as many clinicians as possible, especially in settings where traditional, bulky ECG carts simply aren’t practical. By simplifying the hardware without sacrificing diagnostic depth, we are fundamentally improving access to high-quality cardiac care and reducing the burden of cardiovascular disease in the EU.” Technical Specifications and Capabilities of Kardia 12LKardia 12L is the portable, AI-guided, 12-lead ECG solution whose measurements and ECG interpretation are highly similar to standard 12-lead ECG solutions, right at the point of care, enabling rapid acquisition of complete ECG information and offering a better patient experience. 35 Cardiac Determinations: KAI 12L is the first AI of its kind to detect life-threatening cardiac conditions using a reduced leadset and can identify a comprehensive range of conditions. This includes 14 arrhythmias and 21 morphologies including serious conditions like acute MI and the most common types of cardiac ischemia.Rapid Detection: Specifically designed to expand access to accurate cardiac data across diverse healthcare and acute settings, the system allows for the rapid identification of life-threatening conditions like heart attack.Operational Efficiency: The device weighs just 0.13 kg (0.3 lbs) and is battery-operated, allowing it to be used by HCPs in primary care, urgent care, pharmacy, the home and rural clinics where traditional ECG machines may be impractical due to their size and complexity.Improved Patient and Clinician Experience: The simplified five-electrode setup makes it less invasive for patients, who do not need to fully disrobe during a reading, and typically allows for faster acquisition. Research has shown nearly a 30% reduction in ECG acquisition time compared to standard 12-lead setups. “In a fast-paced clinical environment, every second counts, but we cannot sacrifice accuracy for speed,” said Dr. Alejandro Barbagelata, Adjunct Assistant Professor of Medicine and Cardiology at Duke University. “Kardia 12L offers a unique combination of portability and diagnostic depth, allowing HCPs to make informed care decisions. By streamlining the acquisition process, it enables clinicians to identify life-threatening conditions like MI much faster, leading to better patient outcomes across the board.” Since its FDA clearance and subsequent launch in the United States in June 2024, Kardia 12L has seen growing global adoption including in India, Australia, New Zealand, Vietnam and Canada. The system has been adopted by clinicians across the globe capturing critical heart data on tens of thousands of patients. Most notably, the system has identified over 4,000 instances of MI and ischemia, facilitating life-saving care for those who need it most. This launch comes at a pivotal time, as the European Union reinforces its commitment to tackling cardiovascular diseases–the leading cause of mortality in Europe–through its EU Cardiovascular Health Plan, which prioritizes early detection, prevention, and improved access to care. Kardia 12L will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, and will be followed by additional European countries soon. For more information, please visit: https://alivecor.com/uk/products/kardia12l. Frequently Asked Questions Where is the Kardia 12L ECG System available in Europe? The Kardia 12L ECG System will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, followed by additional European countries soon. This follows the recent receipt of the CE Mark, allowing for its distribution across the European Economic Area. How does Kardia 12L compare to traditional ECG carts? Unlike traditional ECG carts that require 10 leads and bulky hardware, the Kardia 12L uses a unique single-cable, five-electrode design. It is pocket-sized, battery-operated, and uses AI to detect 35 cardiac determinations, making it significantly more portable and faster to deploy in a variety of healthcare facilities and acute settings, including primary and urgent care offices, mobile clinics, in pharmacies, by HCPs in home visits and other underserved or rural venues. How many and what cardiac conditions can the Kardia 12L detect? Powered by KAI 12L AI, the system is cleared to detect 35 cardiac determinations, including 14 arrhythmias (such as Atrial Fibrillation and Atrial Bigeminy) and 21 morphologies. Does the Kardia 12L require specialized training for clinicians? No. The device requires minimal self-guided training. Its simplified five-electrode placement is more intuitive than standard 10-lead setups, which can reduce the risk of lead reversal and shorten the time required for patient preparation. Is the Kardia 12L ECG System intended for home use? The Kardia 12L is intended for use by healthcare professionals in clinical environments including hospitals, urgent care centers, primary care practices, rural clinics, and pharmacy and home visits by an HCP. About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) devices, is transforming cardiology with its medical-grade AI solutions. The company was named to the inaugural TIME World’s Top Health Tech Companies 2025 list – recognition of its commitment to delivering innovative devices and services that empower patients and physicians with personalized, actionable heart data. With over 350 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 cleared to detect 39 cardiac conditions (with determination availability varying by geography), 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 ContactMorgan Mathis Director of Corporate Communications, AliveCor press@alivecor.com Sales Contact OUSenquiries@alivecor.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d510c9dc-7eb1-45bd-ba22-aa01f14d3e40

Kardia 12L ECG System

Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions Using Reduced Leadset

MOUNTAIN VIEW, Calif., April 07, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced the regulatory registration of its Kardia™ 12L electrocardiogram (ECG) System powered by KAI™ 12L AI technology in Vietnam, marking an important step toward expanding AI-enabled cardiac diagnostics across Southeast Asia. The clearance supports Vietnam’s growing commitment to healthcare modernization and strengthens clinicians’ ability to detect and manage cardiovascular disease earlier and more efficiently. Cardiovascular disease remains a leading cause of death globally and across Asia, accounting for 33% of all deaths in Vietnam. Rising rates of hypertension, diabetes, and urbanization-related lifestyle changes are contributing to increasing cardiac risk. At the same time, the Ministry of Health has prioritized digital transformation, hospital capacity optimization, and expanded access to quality care, particularly beyond major urban centers. AI-enabled ECG systems like Kardia 12L align with broader efforts to advance care delivery, support data-driven decision-making, and extend specialist-level insight into frontline settings. Expanding Access to Hospital-Grade Cardiac Insight Kardia 12L is the portable, AI-powered, 12-lead ECG solution whose measurements and ECG interpretation are highly similar to standard 12-lead ECG solutions, right at the point of care, enabling rapid acquisition of complete ECG information and offering a better patient experience. By enabling fast, high-quality diagnostics in clinics, community health centers, and outpatient settings, the platform helps clinicians detect arrhythmias and morphologies including serious conditions like acute myocardial infarction and the most common types of cardiac ischemia earlier, without reliance on traditional, fixed hospital infrastructure. This capability is particularly relevant in Vietnam’s diverse healthcare landscape, where care is delivered across densely populated cities and remote and rural provinces. Kardia 12L supports a more distributed model of cardiac diagnostics, empowering healthcare professionals with accurate, actionable insights wherever patients are seen. Strengthening Healthcare Efficiency and Clinical Confidence Vietnam’s healthcare system continues to manage high patient volumes in major hospitals. Streamlined diagnostic workflows can play a meaningful role in reducing bottlenecks and improving throughput. Kardia 12L’s rapid acquisition and reduced electrode setup simplify the ECG process, shortening preparation time while maintaining diagnostic rigor. The simplified five-electrode setup makes it less invasive for patients, who do not need to fully disrobe during a reading, and typically allows for faster acquisition. Research has shown nearly a 30% reduction in ECG acquisition time compared to standard 12-lead setups. Faster acquisition enables healthcare professionals to move from suspicion to confirmation more quickly, thereby improving triage decisions and accelerating treatment pathways when needed. By combining portability with advanced AI interpretations, the system supports efficient clinician decision making while optimizing patient flow, contributing to both quality and efficiency. Enabling the Next Phase of Digital Cardiac Care As Vietnam advances national digital health initiatives, connected diagnostic tools are becoming increasingly important. Kardia 12L now strengthens AliveCor’s cardiovascular portfolio by standing alongside KardiaMobile and KardiaMobile 6L, creating a unified ecosystem for holistic management of the entire cardiovascular pathway. With its offering expansion into Vietnam, AliveCor reinforces its commitment to supporting healthcare professionals across Southeast Asia with scalable, technology-enabled cardiac solutions designed to improve early detection and expand access to quality cardiovascular care. For more information, sign up for exclusive updates on the Kardia 12L expansion outside of the U.S. here:  https://alivecor.com/uk/forms/kardia-12l-interest-registration. About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) devices, is transforming cardiology with its medical-grade AI solutions. The company was named to the inaugural TIME World’s Top Health Tech Companies 2025 list – recognition of its commitment to delivering innovative devices and services that empower patients and physicians with personalized, actionable heart data. With over 350 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 cleared to detect 39 cardiac conditions (with determination availability varying by geography), 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 Contactpress@alivecor.com  Sales ContactOUSenquiries@aliveor.com  A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7436ab48-0e5f-44b7-9289-6bc166f49740

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MOUNTAIN VIEW, Calif., Dec. 5, 2024 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced that the company has been named 2024 Inc. Best in Business Awards winner in the Innovation and Technology category for Kardia 12L…

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World’s First AI to Detect 35 Cardiac Determinations, Including Heart Attack, Using a Reduced LeadsetPowered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac ConditionsMOUNTAIN VIEW, Calif., June 25, 2024 /PRNewswire/ — AliveCor, the global leader in AI-powered cardiology, today announced the U.S. Food & 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.

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Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions Using Reduced Leadset

Pocket-Sized Kardia 12L ECG System

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 AliveCorAliveCor, 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 ContactsSu Leeslee191@alivecor.com(562) 544-4634Ben Rickles[email protected](404) 502-6766SOURCE AliveCor, Inc.