For HCPs, Request Your Two-week Kardia 12L Trial Today | Inquire Now

AliveCor Logo

Our Technology

Our Devices

Kardia 12L

New

KardiaMobile 6L
K1000 (InstantQT)
Our Personal EKGs

Our Software

KardiaPro
KardiaStation
KardiaComplete
KardiaCare Plus
API & SDK Solutions
Our AI

Our Solutions

For Physicians & Providers
For Health Systems & Clinics

For Life Sciences Industry

Clinical Trials
Patient Engagement
For Employers
For Veterans Affairs
For Payors
For Consumers

About

Mission
Leadership
The Human Component Film
Newsroom
Clinical Research
(855) 338-8800
AliveCor Logo
AliveCor Logo
  • Instagram
  • Facebook
  • Twitter
  • LinkedIn
    • (855) 338-8800
    • Mission
    • Careers
    • Research
    • Newsroom
    • FAQs
    • User Manuals
    • Compatibility
    • Shipping
    • (855) 338-8800
    • KardiaMobile Card
    • KardiaMobile 6L
    • KardiaMobile
    • KardiaCare
    • International
  • Instagram
  • Facebook
  • Twitter
  • LinkedIn
  • Privacy Policy
  • Security
  • Telehealth Informed Consent
  • Terms
  • Accessibility

©2024 AliveCor, Inc. All Rights Reserved. Patents www.alivecor.com/patents. AliveCor and Kardia are trademarks of AliveCor, Inc. in the United States and other countries. Apple is a trademark of Apple, Inc. registered in the U.S. and other countries. App Store is a service mark of Apple, Inc. Android is a trademark of Google Inc. Google Play is a trademark of Google Inc.

Go Back
AliveCor Receives First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device
SAN FRANCISCO Calif., August 21, 2014

Patients are able to instantly identify atrial fibrillation in real-time ECG recordings

AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. AliveCor’s automated analysis process (algorithm) instantly detects if patients are experiencing AFib through real-time electrocardiogram (ECG) recordings taken on the mobile phone based AliveCor® Heart Monitor, so physicians can intervene before potentially life-threatening conditions, like strokes, occur. Through AliveCor’s ECG analysis service, patients can confirm their results with a U.S. board-certified cardiologist or a personal physician.

“The ability to automatically detect serious heart arrhythmia using mobile technology has the potential to save lives, reduce healthcare costs and allow patients and their caregivers to make informed decisions about cardiac care,” said Euan Thomson, president and chief executive officer of AliveCor. “Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September.”

One in four adults over age 40 develop AFib, making them five times more likely to have a stroke. AFib can be hard to detect, as symptoms, including heart palpitations, may be mild or non-existent. The AFib Detector represents a major step in the advancement of mobile phone based health, allowing patients to instantly know if AFib is present in their ECG. The company hopes to collect additional data and develop other algorithms over time.

“AliveCor is truly delivering on the promise of mobile health, placing medically relevant, intelligent tools in the hands of consumers worldwide,” said Trudie Lobban MBE, Founder & CEO of AF Association & Arrhythmia Alliance. “We are excited about this milestone and look forward to using this technology to help those who suffer from arrhythmias identify when AFib is present in an effective and efficient way so they can work with their doctors to manage their condition.”

The AliveCor Heart Monitor is intended to record, store and transfer electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The AliveCor Heart Monitor is compatible with all iPhone models and most Android mobile devices. Users will continue to have the ability to access their data confidentially anytime, anywhere.

For customers in the U.S., AliveCor Heart Monitor can be purchased at www.alivecor.com .

Let's transform cardiovascular care together

If you are an employer or payer looking for a comprehensive heart health enterprise solution, contact us.