FDA clears AliveCor's automated detectors that record and display ECG rhythm

AliveCor, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for two new algorithms giving users instant feedback on their electrocardiogram (ECG) recordings and expanding its automated interpretation service offerings.

AliveCor's new analysis processes (algorithms) include a Normal Detector that identifies when no abnormalities are detected in an ECG recording and an Interference Detector that identifies if factors have affected the recording making the ECG unreadable. Together with the previously cleared atrial fibrillation (AF) detection algorithm (AF Detector), these two new detectors will continue to ensure patients and their healthcare providers receive accurate and relevant real-time interpretations of mobile ECG recordings.

The Normal Detector will immediately display to users when no abnormalities are found in their ECG recording. If an abnormality is detected apart from AF, the AliveECG app will tell users the rhythm is undetermined. A recent AliveCor survey found that nine out of 10 people concerned with heart health are very interested in being able to instantly find out if their ECG is normal. With this new detector users will have added peace of mind getting instant confirmation that their ECG is normal.

The other new detector, the Interference Detector, will notify users immediately if there is any interference in a recording, sometimes called noise or artifact, which can make it difficult for healthcare providers to interpret an ECG. Interference can get picked up when there is too much muscle tension or movement in the hands, or if a recording is taken in an area with excessive noise. Users will be notified of interference and prompted on how to retake the recording to help ensure a high-quality ECG is captured.

"With the new FDA clearance for the implementation of additional algorithms, the AliveCor Heart Monitor will be able to provide immediate feedback to patients which may help alleviate some of their anxiety over arrhythmias. In addition, the ability to provide multiple types of analyses further empowers both patient and physician and allows for the delivery of more efficient care and follow-up, ultimately, reducing health care costs," said Kevin R. Campbell, MD, FACC, North Carolina Heart and Vascular UNC Healthcare, clinical cardiac electrophysiology assistant professor, UNC Department of Medicine, Division of Cardiology, director of electrophysiology, Johnston Health and President, K-Roc Consulting, LLC.

"Our goal for creating these two new detectors was to expand our automated services based on the millions of ECGs now in our database and provide patients with the information they have told us they want at their fingertips," said Euan Thomson, president and chief executive officer at AliveCor. "We know first hand that our customers want the immediate reassurance of knowing when their ECG is normal. With these new detection capabilities, patients, along with their healthcare providers can focus on reviewing those ECGs that are most concerning while also working to understand what lifestyle factors may be contributing to both their normal or abnormal recordings."

The AliveCor® Heart Monitor is intended to record, store and transfer single-channel ECG rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (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 device has not been tested for and it is not intended for pediatric use. The AliveCor Heart Monitor is compatible with all iOS and most Android OS mobile devices. With secure storage in the cloud, users have the ability to access their data confidentially anytime, anywhere.

These new features are expected to be available in the AliveECG app this quarter for customers in the U.S., UK, Ireland, Australia and India. The AliveCor Heart Monitor can be purchased in the U.S. at store.alivecor.com, Amazon or Omron Healthcare, a leading manufacturer of home blood pressure monitors and in the UK and Ireland at Amazon.


AliveCor, Inc.


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