FDA Grants First Ever Clearance For Six-Lead Personal ECG Device
MOUNTAIN VIEW, Calif., May 13, 2019
MOUNTAIN VIEW, Calif., May 13, 2019
KardiaMobile® is the Only Personal ECG that Delivers Multi-Dimensional Insight into a Patient's Heart
AliveCor, the leader in FDA-cleared consumer electrocardiogram technology (ECG), today announced its third FDA clearance in three months, making KardiaMobile 6L the world’s first available six-lead personal ECG device. This highly anticipated clearance gives patients and their physicians an even more detailed view into patients’ hearts, including visibility into certain arrhythmias that are leading indicators of cardiovascular disease.
“KardiaMobile 6L is the most clinically valuable personal ECG ever created, and another significant step in AliveCor’s march to making heart care more convenient, more accessible, and less expensive than ever before” said AliveCor CEO Ira Bahr.
The KardiaMobile six-lead device is consistent in design with AliveCor’s existing KardiaMobile. But, in addition to the two electrodes on the top of the device, there is one additional electrode on the bottom. The user places her thumbs on each of the two top electrodes, and places the bottom electrode on her left knee or ankle. This formation, known in cardiology as the Einthoven Triangle, allows cardiologists to view electrical activity in the heart from six perspectives or “leads.” A six-lead ECG provides physicians with a far superior view of the heart than a single lead ECG, giving them ability to detect a far broader range of arrhythmias and other heart conditions, all without the hassle of gels or wires.
“I am impressed with the quality and simplicity of 6-lead smartphone ECG tracings which will unquestionably sharpen our ability to diagnose heart rhythm and conduction abnormalities. It’s a welcome and needed step forward for mobile heart diagnostics,” said Eric Topol, MD, cardiologist, Founder and Director or Scripps Research Translational Institute, and author of the new book “Deep Medicine.”
“I am as excited for patients as I am for doctors with this clearance. One more step toward providing patients with the tools they need to drive excellence in digital healthcare,” said Leslie Saxon MD, Professor of Medicine, Clinical Scholar Keck School of Medicine, USC and Executive Director, USC Center for Body Computing.
KardiaMobile 6L will be available in June and may be pre-ordered today at KardiaMobile6L.com
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. Neither Dr. Topol, nor Dr. Saxon have financial relationships with Alivecor.
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