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Three New Studies Confirm Clinical Utility of AliveCor's KardiaMobile Device and AI Algorithms
MOUNTAIN VIEW, Calif. and NEW ORLEANS, March 18, 2019 /PRNewswire/ -- AliveCor, the leader in FDA-cleared personal electrocardiogram technology (ECG), today announced three new studies that demonstrate both the clinical utility and workflow advantages of its mobile ECG platform.
The Lancet's EClinicalMedicine published research from the University of Edinburgh and NHS Lothian which demonstrated that in a randomized controlled trial of 243 people – who presented to 10 hospitals in the UK with heart palpitations or pre-syncope – ECGs taken with KardiaMobile after discharge allowed doctors to diagnose 56 percent of patients in 9.5 days on average. This compared to patients who received standard care, where 10% were diagnosed in an average of 43 days. The research also found that cost per-treated patient using KardiaMobile could also be reduced by nearly $1,200. The researchers concluded that KardiaMobile "should be considered part of on-going care to all patients presenting acutely with unexplained palpitations or pre-syncope."
Two studies were presented this weekend at the American College of Cardiology Scientific Sessions in New Orleans:
- Dr. Ronald Karlsberg from the Cardiovascular Research Foundation of Southern California, demonstrated that AliveCor's Remote Patient Monitoring platform, KardiaPro, can be integrated into an Electronic Health Records platform (EPIC) to allow KardiaMobile ECGs to be analyzed, interpreted, and recorded into the patient's medical record for more robust documentation and treatment decision making. Simultaneously, AliveCor announced the latest version of KardiaPro which supports reimbursement under the newest Remote Patient Monitoring CPT codes.
- AliveCor data scientists, in collaboration with Mayo Clinic, showed that KardiaMobile Generation 2--AliveCor's six lead mobile ECG (pending 510(k) clearance)--can accurately measure the QT interval, which, when prolonged, is associated with sudden cardiac death. AliveCor trained a deep neural network using ECG data from over 200,000 Mayo Clinic patients to predict the QT interval. The algorithm was then tested on prospectively collected ECG data from 323 patients in Mayo Clinic's Heart Rhythm Clinic. The neural network's QT prediction from KardiaMobile Generation 2 ECG data was comparable to the QT measured from a traditional 12-lead ECG. This research presents a convenient and accurate means for early detection of long QT syndrome, for which millions of patients are at risk of due to use of certain medications including antibiotics and antidepressants.
"KardiaMobile is the most clinically validated mobile ECG in the world," said Dr. Jacqueline Shreibati, Chief Medical Officer at AliveCor. "Every day, physicians and patients around the globe reaffirm AliveCor's role in improving patient outcomes. AliveCor is proud to be involved in high-quality clinical research, including randomized controlled trials, and prospective validation studies of AI algorithms."
AliveCor continues to lead the digital health industry with new products. In September 2018, AliveCor announced that it's developing KardiaMobile Gen 2, a six-lead, consumer-facing ECG device – pending FDA clearance – that gives patients and physicians even more detailed information about heart health. KardiaMobile Generation 2 was demonstrated at the American College of Cardiology Scientific Sessions in New Orleans.
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, and KardiaBand, when paired with the Kardia app provide instant analysis for detecting atrial fibrillation (AF) and normal sinus 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. For more information, visit alivecor.com.
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