The developer of the one of the most widely used wearable ECG monitors has received clearance for two new algorithms that enable users to instantly know if their ECG readings are normal or possibly contaminated by outside sources.
San Francisco-based AliveCor announced that the U.S. Food and Drug Administration has approved the Normal Detector algorithm, which gives a user instant feedback that no abnormalities are detected in an ECG, and Interference Detector, which identifies if outside factors are negatively affecting the reading. Those outside factors – sometimes called interference or an artifact - may include noise, muscle tension or excessive hand movements.
Designed not only to give users peace of mind, the algorithms also help providers to more quickly pinpoint the cause of an abnormal ECG, thus speeding up time to treatment and improving clinical outcomes.
The AliveCor Heart Monitor records, stores and displays single-channel ECG rhythms through the AliveCor ECG app, which is compatible with most Android and iOS devices. The solution is primarily intended for physicians to prescribe to their patients (it hasn't been tested for pediatric use), though it can be purchased by consumers through AliveCor, Omron Healthcare or Amazon.
The mobile device allows a user to measure normal sinus rhythm or, through the AF Detector algorithm, atrial fibrillation. If an abnormality is detected in an ECG that can't be attributed to AF, the app indicates that the cause is undetermined.
Company officials said that a recent survey of users found that nine of 10 "are very interested in being able to instantly find out if their ECG is normal." They'd also like to know if irregular ECG readings can be attributed to other causes.
“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, AliveCor's president and CEO, in a press release. “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.”
