• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

FDA Clears AliveCor’s Heart Attack-Detecting AI Kardia 12L ECG System

by Fred Pennic 06/25/2024 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know: 

– AliveCor, a leader in AI-powered cardiology, has received FDA clearance and launched a groundbreaking innovation – the Kardia™ 12L ECG System with KAI™ 12L AI technology. 

– AliveCor’s Kardia 12L ECG System signifies a major advancement in cardiac diagnostics. By combining cutting-edge AI technology with a portable and user-friendly design, the system empowers healthcare professionals to deliver faster, more accurate, and more accessible cardiac care. 

Unmatched Accuracy with Reduced Complexity

The Kardia 12L ECG System stands out for its unique combination of features:

  • AI-Powered Accuracy: The KAI 12L AI technology utilizes deep neural networks trained on over 1.75 million ECGs. This empowers the system to detect a wide range of cardiac conditions, including 35 different determinations (14 arrhythmias and 21 morphologies) with exceptional accuracy. Notably, it can identify life-threatening issues like heart attacks using a reduced leadset.
  • Pocket-Sized Convenience: Traditional 12-lead ECG machines are bulky and often limited to clinical settings. The Kardia 12L, weighing only 0.3 pounds, is a highly portable device that can be used virtually anywhere.
  • Simplified User Experience: Unlike conventional ECG machines, the Kardia 12L requires minimal training and utilizes a streamlined single-cable design with five electrodes. This reduces patient discomfort and streamlines the ECG acquisition process.
  • Broader Accessibility: The Kardia 12L’s compactness, user-friendliness, and affordability open doors to wider adoption in various healthcare settings. This includes primary care offices, urgent care clinics, employer-based health facilities, and even rural or under-resourced environments.

Transforming Cardiac Care Delivery

The Kardia 12L ECG System offers several advantages for healthcare providers and patients alike:

  • Faster Diagnosis: Rapid access to high-quality ECG data allows for earlier detection of heart conditions, potentially leading to faster and more effective treatment.
  • Improved Patient Experience: The streamlined design and ease of use make the Kardia 12L less invasive and more comfortable for patients.
  • Enhanced Care Accessibility: The portability and affordability of the system open doors to providing advanced cardiac care in a wider 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.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance, FDA clearance 510k

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

2025 EMR Software Pricing Guide

2025 EMR Software Pricing Guide

Featured Interview

Kinetik CEO Sufian Chowdhury on Fighting NEMT Fraud & Waste

Most-Read

Blue Cross Blue Shield of Massachusetts Launches "CloseKnit" Virtual-First Primary Care Option

Blue Cross Blue Shield of Massachusetts Launches “CloseKnit” Virtual-First Primary Care Option

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

2019 MedTech Breakthrough Award Category Winners Announced

MedTech Breakthrough Announces 2025 MedTech Breakthrough Award Winners

WeightWatchers Files for Bankruptcy to Eliminate $1.15B in Debt

WeightWatchers Files for Bankruptcy to Eliminate $1.15B in Debt

KLAS: Epic Dominates 2024 EHR Market Share Amid Focus on Vendor Partnership; Oracle Health Sees Losses Despite Tech Advances

KLAS: Epic Dominates 2024 EHR Market Share Amid Focus on Vendor Partnership; Oracle Health Sees Losses Despite Tech Advances

'Cranky Index' Reveals EHR Alert Frustration Peaks Midweek, Highest Among Admin Staff

‘Cranky Index’ Reveals EHR Alert Frustration Peaks Midweek, Highest Among Admin Staff

Madison Dearborn Partners to Acquire Significant Stake in NextGen Healthcare

Madison Dearborn Partners to Acquire Significant Stake in NextGen Healthcare

Wandercraft Begins Clinical Trials for Physical AI-Powered Personal Exoskeleton

Wandercraft Begins Clinical Trials for Physical AI-Powered Personal Exoskeleton

Chipiron Secures $17M to Transform MRI Access with Portable Scanner

Chipiron Secures $17M to Transform MRI Access with Portable Scanner

Abbott to Integrate FreeStyle Libre Glucose Data with Epic EHR

Abbott to Integrate FreeStyle Libre Glucose Data with Epic EHR

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |