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FDA Clears Two AliveCor Algorithms for Use in ECG Recordings
29 January 2015 - The US Food and Drug Administration has granted US-based heart health technology developer AliveCor, Inc. clearance for two new algorithms designed to give users instant feedback on their electrocardiogram recordings, the company said on Thursday.

AliveCor said its 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 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, the company said. If an abnormality is detected apart from AF, the AliveECG app will tell users the rhythm is undetermined. 

A recent survey by AliveCor found that nine out of ten 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.

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).

AliveCor said that these new features are expected to be available in the AliveECG app this quarter for customers in the US, UK, Ireland, Australia and India.
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