AliveCor said the FDA approved 2 new algorithms for its eponymous heart monitoring app, which is designed to detect abnormal heart rhythms using a single-channel electrocardiogram.
The 1st algorithm is designed to alert users if their ECG is normal; the 2nd notifies them if the ECG is unreadable due to interference, according to a press release.
The new algorithms will run alongside the device’s existing algorithm, which notifies the user if atrial fibrillation is detected. ECGs can also be transmitted to a physician for further analysis.
“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 AliveCor CEO Euan Thomson, in a statement.
“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,” Thomson added.
AliveCor’s AF algorithm won a nod from the FDA last August and just last month won CE Mark approval in the European Union.