KardiaAI

by AliveCor  · Based in United States → — Transforming cardiology with its medical-grade AI solutions.
Cardiology Emergency Medicine Internal Medicine
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Subscription-based for integrated services
Regulatory Status Disclosed

Overview

KardiaAI, developed by AliveCor, is an FDA-cleared AI-powered software analysis library designed to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. Operating as a Software as a Medical Device (SaMD), it processes various physiological parameters from 30-second ECGs. The capabilities of KardiaAI are provided as an Application Program Interface (API) library, allowing it to be integrated into other compatible ECG devices and mobile applications.

The tool performs essential functions such as ECG noise filtering and the detection of noisy ECGs. Its core analytical strength lies in identifying a range of cardiac conditions, including normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia. Furthermore, KardiaAI can detect more nuanced conditions like Sinus Rhythm with Premature Ventricular Contractions (PVCs), Sinus Rhythm with Wide QRS, and Sinus Rhythm with Supraventricular Ectopy (SVE), providing comprehensive heart rhythm analysis for healthcare professionals and patients.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered ECG analysis library
  • Detection of atrial fibrillation, bradycardia, tachycardia, and normal sinus rhythm
  • Detection of Sinus Rhythm with Premature Ventricular Contractions (PVCs)
  • Detection of Sinus Rhythm with Wide QRS
  • Detection of Sinus Rhythm with Supraventricular Ectopy (SVE)
  • ECG noise filtering and noisy ECG detection
  • API library for integration into other ECG devices and software
  • Medical-grade accuracy for heart rhythm data
  • Supports 6-lead and 12-lead ECG analysis (via integrated devices)
  • Remote heart rhythm monitoring capabilities

Use Cases

  • Remote heart rhythm monitoring for patients
  • Early detection and management of atrial fibrillation and other arrhythmias
  • Supporting clinical research and trials
  • In-office ECG solutions for rapid assessment (via KardiaStation)
  • Remote patient management for healthcare professionals (via KardiaPro)
  • Disease and safety monitoring in biopharma

What Physicians Need to Know

ECG/EKG Analysis Capability
KardiaAI, through devices like KardiaMobile (single-lead), KardiaMobile 6L (six-lead), and the Kardia 12L ECG System (handheld 12-lead), provides medical-grade, FDA-cleared ECG recordings. The AI can detect 35 cardiac determinations, including 14 arrhythmias and 21 morphologies, such as acute myocardial infarction (MI) and cardiac ischemia with the KAI 12L technology. KardiaMobile devices specifically detect 6 common arrhythmias: Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy (SVE), Sinus Rhythm with Premature Ventricular Contractions (PVCs), and Sinus Rhythm with Wide QRS. Recordings are typically captured in 30 seconds and the Kardia app provides instant analysis. KardiaMobile 6L also allows for QT interval measurement.
Arrhythmia Detection Accuracy
KardiaMobile's AFib detection algorithm demonstrates high accuracy, with 96.6% sensitivity and 94% specificity compared to expert cardiology over-read of 12-lead EKGs. KardiaMobile 6L shows 99% sensitivity and 97% specificity for atrial fibrillation and double the accuracy for atrial flutter detection compared to single-lead smartwatches. The Kardia AI V2 algorithm suite has improved sensitivity and specificity for 'Normal' and 'Atrial Fibrillation' algorithms, reducing unclassified readings, false positives, and false negatives. The KAI 12L AI technology is trained and validated on over 1.75 million ECGs.
Heart Failure Risk Prediction
While not a direct feature of the KardiaAI ECG devices, the separate Kardia.ai platform provides an AI-driven prediction of 1-year mortality or severe decompensation risk in heart failure patients, utilizing EHR data and multimodal cardiac imaging. Research also suggests the potential for AI models using lead I ECGs for heart failure risk stratification.
Coronary Artery Assessment
The KAI 12L AI technology, integrated with the Kardia 12L ECG System, is capable of detecting serious conditions such as acute myocardial infarction (MI) and common types of cardiac ischemia using a reduced leadset. A case report also demonstrated the ability of a single-lead Kardia device to detect ST-segment elevation during chest pain, indicating an acute coronary event.
Cardiac Monitoring Integration
AliveCor offers robust integration capabilities through its Software Developer's Kit (SDK) and Application Programming Interface (API). KardiaMobile 6L integrates with Epic's App Orchard Marketplace via KardiaPro, allowing seamless pulling of ECGs into EHR systems. KardiaPro is a HIPAA-compliant, SOC-2 certified web-based portal for remote monitoring of ECG, blood pressure, and weight data, and integrates with KardiaStation for in-office use. Partnerships, such as with Delve Health, enable integration into remote patient monitoring (RPM) gateways.
AHA/ACC Guideline Alignment
KardiaAI devices are FDA-cleared and considered medical-grade, with extensive clinical validation and over 200 clinical publications. The Kardia 12L ECG System has demonstrated performance comparable to a standard hospital-grade ECG for detecting morphological cardiac abnormalities. Studies supporting its efficacy have been published in reputable journals, including one related to 'Circulation, The Journal of the American Heart Association'.
Real-Time Alert Capability
The Kardia app provides instant analysis of recorded ECGs. KardiaPro allows physicians to customize their ECG Inbox to prioritize abnormal recordings for review. AliveCor Labs offers 24/7 monitoring and real-time analysis by certified technicians. The new KardiaAlert feature, available with KardiaMobile 6L Max, compares current ECGs against a baseline to detect subtle changes over time. Webhook notifications can alert integrated systems when new ECG data is available. The KardiaStation app provides instant heart rhythm determinations in a clinical setting.
Physician Tip

KardiaAI offers a versatile suite of tools for both in-office and remote cardiac monitoring. Leverage KardiaMobile 6L for quick, medical-grade 6-lead ECGs in clinic, and utilize KardiaPro for efficient remote patient management, trend analysis, and streamlined data review, especially for abnormal rhythms. The Kardia 12L ECG System provides a portable, AI-powered 12-lead solution for rapid detection of a broad range of conditions, including MI and ischemia, potentially enhancing diagnostic efficiency in various healthcare settings. Emphasize patient education on proper device use to maximize data quality and encourage consistent monitoring for early detection of arrhythmias and other cardiac events. Integrate Kardia data into existing EHR systems to ensure comprehensive patient records and facilitate timely clinical decision-making.

AliveCor provides robust integration options, including SDKs and APIs, to allow seamless incorporation of ECG data into various healthcare ecosystems. Key integrations include KardiaPro's availability on Epic's App Orchard Marketplace and partnerships with cardiac information management systems like GE Healthcare's MUSEu2122 NX, enabling automated data flow into EHRs. This facilitates remote patient monitoring workflows and supports data-driven insights for both clinical practice and research, ensuring HIPAA compliance and data security.

Details

Category Cardiology AI
Pricing Subscription-based for integrated services — KardiaCare Monthly: $13.99/month; KardiaCare Annual: $99.99/year; KardiaCare Plus: $199/year
DeploymentSoftware as a Medical Device (SaMD), API library integrated into mobile apps and web platforms
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

KardiaAI received 510(k) clearance K181823 on March 06, 2019, as a programmable diagnostic computer, and further clearance K201985 on November 12, 2020, for its software analysis library to assess ambulatory ECG rhythms.
Integrations
EHR Not specified
Specialties Cardiology, Emergency Medicine, Internal Medicine

What the Web Says

KardiaAI, developed by AliveCor, is widely recognized for its personal ECG devices that allow users to record medical-grade EKGs at home. It's praised by physicians for its accuracy in detecting arrhythmias like atrial fibrillation, and by users for its ease of use and ability to share data with healthcare providers. However, some concerns exist regarding the interpretation of results without professional medical advice and the subscription model for advanced features.

Overall: Positive

Strengths

  • High accuracy in detecting AFib and other arrhythmias
  • User-friendly interface and portable design
  • Ability to share ECG data directly with physicians
  • FDA-cleared and medically validated technology
  • Empowers patients to monitor their heart health proactively
  • Integration with some EHR systems for seamless data flow

Limitations

  • Subscription required for advanced features and detailed analysis (KardiaCare)
  • Can lead to user anxiety if results are misinterpreted without medical guidance
  • Not a substitute for a full 12-lead ECG or professional medical diagnosis
  • Some users report occasional difficulty in getting a 'good' reading
  • Cost of the device and ongoing subscription can be a barrier for some
  • Limited detection capabilities compared to a clinical ECG

Based on reviews from: Physician reviews (various medical forums and journals), Healthcare IT publications, Tech reviewer websites (e.g., TechCrunch, CNET), Reddit (r/KardiaMobile, r/health), G2, Capterra

Last updated: 2026-07-21

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Press & Coverage

Cardiac Rhythm News
AliveCor announces US FDA clearance of new cardiac determinations for Kardia 12L ECG system
AliveCor received FDA clearance for the next generation of its KAI 12L AI technology, powering the Kardia 12L ECG system, to detect five additional cardiac determinations, bringing the total to 39. This expansion enhances the diagnostic capabilities of the AI-powered, handheld 12-lead ECG system.
2026-01
PR Newswire
AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System
AliveCor announced dual FDA clearance and commercial launch of KAI 12L AI technology and the Kardia 12L ECG System, the world's first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System is a handheld, AI-powered 12-lead ECG system with a unique single-cable design.
2024-06
HCPLive
FDA Clears AI Program Powering Kardia 12L Electrogram for 5 New Cardiac Determinations
AliveCor's KAI 12L, the AI powering Kardia 12L, received FDA clearance for five new cardiac determinations, increasing the total to 39. These new determinations include rhythm modifiers like short PR interval, atrial bigeminy, and ventricular bigeminy, as well as left and right axis deviation.
2026-01
HLTH
AliveCor Secures FDA Clearance for Expanded Cardiac Determinations in Kardia 12L ECG System
AliveCor announced FDA clearance for the next generation of KAI 12L, the AI engine for the Kardia 12L ECG System, adding five new cardiac determinations for a total of 39. This expands the system's diagnostic scope and provides clinicians with more insights from the handheld device.
2026-01
Diagnostic and Interventional Cardiology
AliveCor's ECG System Receives FDA Approval
AliveCor received FDA clearance for the next generation of KAI 12L, the AI powering the Kardia 12L ECG System, to detect five additional cardiac determinations, bringing the total to 39. The Kardia 12L system is a portable, single-cable, five-electrode device designed for rapid cardiac assessment.
2026-01
BioSpace
AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39
AliveCor announced FDA clearance for the next generation of KAI 12L, the AI powering the Kardia 12L ECG System, to detect five additional cardiac determinations, bringing the total to 39. This expands the diagnostic capabilities of the world's first AI-powered, handheld 12-lead ECG system.
2026-01
Sensors (Basel, Switzerland)
A Crowdsourced AI Framework for Atrial Fibrillation Detection in Apple Watch and Kardia Mobile ECGs
This study developed a robust, generalizable AFib detection approach for mobile ECG devices using crowdsourced algorithms, demonstrating high performance across various datasets. The voting algorithm outperformed base algorithms and Apple's algorithm, showing higher specificity but lower sensitivity than AliveCor's Kardia algorithm.
2024-09
Harvard Business School
Alivecor & Neurobit: Data-Acquisition Strategies for AI in Healthcare
This publication discusses data acquisition strategies for AI in healthcare, featuring AliveCor and Neurobit. It explores the challenges of data acquisition, privacy concerns, and regulatory compliance that healthcare startups face in leveraging AI.
2024-06

Videos

Product demos, reviews, and walkthroughs for KardiaAI.

View all on YouTube

Frequently Asked Questions

KardiaAI, through devices like KardiaMobile 6L and Kardia 12L, enables rapid ECG acquisition in-office or remotely by patients. The collected data is then securely uploaded to the HIPAA-compliant and SOC-2 certified KardiaPro physician portal, facilitating efficient review and integration into clinical decision-making.
KardiaAI devices and algorithms are FDA-cleared for various cardiac determinations, including the detection of multiple arrhythmias and morphologies. AliveCor, the developer of KardiaAI, ensures robust data security and privacy through HIPAA compliance attestation, SOC 2 Type 2 certification, and ISO 27001 certification.
While effective for detecting many arrhythmias, KardiaAI's single-lead devices may have limitations in providing the same comprehensive detail as a full 12-lead ECG for complex conditions. Some studies indicate differences in interval measurements (e.g., PQ, QT) compared to standard ECGs, and the system is not intended for life-supporting systems or pediatric use.
KardiaAI offers a portable, AI-powered alternative to traditional 12-lead ECG machines and Holter monitors, providing rapid, on-demand or continuous monitoring for various arrhythmias. It has been shown to reduce urgent healthcare utilization and facilitate earlier detection of conditions like Atrial Fibrillation, complementing rather than fully replacing comprehensive diagnostic tools.
While specific pricing for physician practices isn't publicly detailed, consumer Kardia devices range from approximately $79 to $149. For professional use, the KardiaPro platform supports reimbursement using existing CPT codes for remote patient monitoring, and new CPT Category III codes for the Kardia 12L system were established in 2024, with Medicare payment approved in hospital outpatient settings in 2025.
KardiaAI's FDA-cleared algorithms can detect up to 35 rhythms and morphologies, including Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Premature Ventricular Contractions, and with Kardia 12L, acute myocardial infarction and ischemia. Its diagnostic accuracy for Atrial Fibrillation detection is comparable to standard ECGs, demonstrating high sensitivity and specificity.

Compare KardiaAI

VS
KardiaAI vs Cardiomo
Cardiology AI Adjacent · 75/100
KardiaAI and Cardiomo are adjacent competitors, both leveraging AI for cardiac condition detection and remote monitoring. KardiaAI focuses on providing an FDA-cleared AI software library for analyzing ECG…
VS
KardiaAI vs EchoNext
Cardiology AI Adjacent · 70/100
Both KardiaAI and EchoNext are FDA-cleared AI tools that analyze ECGs for cardiac conditions, making them adjacent competitors in the cardiology AI space. KardiaAI focuses on detecting various…
VS
KardiaAI vs PMcardio
Cardiology AI Direct · 85/100
KardiaAI and PMcardio are direct competitors, both offering AI-powered ECG interpretation for cardiac condition detection. KardiaAI focuses on an API library for integration into other devices and mobile…
VS
Merge PACS vs KardiaAI
Cardiology AI Adjacent · 60/100
Merge PACS is an enterprise-level Picture Archiving and Communication System that integrates AI for radiology and cardiology imaging workflows across multi-site health systems, focusing on image management and…

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed KardiaAI

Funded through the company that built this tool.

Qualcomm Ventures Healthcare
Corporate VC T3
San Diego, United States
$1M-$5M
Qualcomm Ventures Healthcare is the healthcare-focused activity of Qualcomm Ventures, the strategic investment arm of Qualcomm. The fund’s healthcare thesis follows directly…
Digital Health Medical Devices / MedTech
Mayo Clinic Ventures
Corporate VC T3
Rochester, United States
$250k-$1M
Mayo Clinic Ventures is the commercialization and venture arm of Mayo Clinic, investing in companies that align with the institution’s clinical and…
AI/ML in Healthcare Biotech
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