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Devices Monitoring Cardiology FDA

 News Release - April 23, 2019

FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device

KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias

MOUNTAIN VIEW, Calif., April 23, 2019 -- (Healthcare Sales & Marketing Network) -- AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced two additional FDA 510(k)-cleared indications, making KardiaMobile the only consumer ECG device in the world with FDA-clearance to detect the three most common heart arrhythmias.

In addition to detecting Atrial Fibrillation (AFib) and Normal Sinus Rhythm, AliveCor, starting today, is able to detect and show ECG results for Bradycardia and Tachycardia. These instant analyses indicate arrhythmias that are not AFib and that are between 40-50 beats per minute (Bradycardia), or between 100-140 beats per minute (Tachycardia).

"No other consumer ECG device in the world, can tell you more about your heart than KardiaMobile," said AliveCor Chief Executive Officer, Ira Bahr. "Until today, patients have been frustrated when devices label their ECG reading as 'unclassified' or 'inconclusive.' Starting today, KardiaMobile is the first personal ECG device that can begin to materially reduce the number of those determinations. Critically, KardiaMobile is also the only personal ECG that can detect Atrial Fibrillation at heart rates above 120, and heart rates below 40."

Bradycardia and tachycardia, which literally mean "slow heart" and "fast heart", respectively, occur in nearly all adults. While the normal range of heart rate is between 50 and 100 beats per minute, there are many scenarios where the rate can be slightly out of this range. For example, the heart may slow below 50 beats per minute during sleep, and naturally, in many healthy adults and athletes. A fast heart rate may naturally occur in response to exercise, anxiety, or pain.

While Bradycardia and Tachycardia are often benign, these arrhythmias can be indicative of heart disease or other health conditions, such as thyroid disease. A slow or fast heart rate may be asymptomatic, or cause symptoms such as dizziness or shortness of breath. KardiaMobile users will now be able to detect these arrhythmias and use the insight to inform conversations with their doctor. Beyond the patient-doctor relationship, KardiaMobile also provides peace of mind by diminishing the number of unclassified readings that users may receive.

"Tachycardia and bradycardia are common because they are often the body's natural response to everyday life, from physical activity and sleep to emotions and overall health," said Dr. Jacqueline Shreibati, CMO of AliveCor. "While we have traditionally focused on the patient empowerment that comes from increased awareness of atrial fibrillation, we are excited to give all of our users more actionable insights into their heart health."

To learn more about AliveCor and the new indications, visit: www.alivecor.com/

About AliveCor

AliveCor, Inc. is pioneering the creation of FDA-cleared machine learning techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared KardiaMobile is the most clinically validated mobile ECG solution on the market. It is recommended by leading cardiologists and used by people worldwide for accurate ECG recordings. KardiaMobile when paired with the Kardia app, provides instant analysis for detecting Atrial Fibrillation, Bradycardia, Tachycardia, and Normal rhythm in an ECG. Kardia is the first A.I. enabled platform to help clinicians manage patients for the early detection of atrial fibrillation, the most common cardiac arrhythmia and one that leads to a five times greater risk of stroke. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. The new KardiaPro platform is the only Remote Patient Monitoring platform that works with the existing devices that patients use. KardiaPro now supports reporting for contemporary CPT codes including 99091 and 99457. AliveCor was named the No.1 artificial intelligence company on Fast Company's Top 50 Most Innovative Companies, in addition to ranking 20th overall in an evaluation of thousands of companies worldwide. AliveCor owns pending patent applications and issued patents covering ideas presented in this press release including issued U.S. Patent Numbers 9,839,363; 9,572,499; 9,986,925; 9,833,158; 9,351,654; 9,220,430; and 9,579,062. AliveCor is a privately-held company headquartered in Mountain View, Calif. "Consumer" or "Personal" ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.


Source: AliveCor

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