FDA Clears New Mobile ECG Algorithms
The U.S. Food and Drug Administration has granted remote cardiac monitoring technology developer AliveCor marketing clearance for two new algorithms, giving users instant feedback on their electrocardiogram recordings and expanding its automated interpretation service offerings.
The U.S. Food and Drug Administration has granted remote cardiac monitoring technology developer AliveCor marketing clearance for two new algorithms, giving users instant feedback on their electrocardiogram recordings and expanding its automated interpretation service offerings.
AliveCors 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," company executives said in a statement.
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, the company says 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, 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 cloud-based AliveCor Heart Monitor app is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device is not intended for pediatric use. It is compatible with all iOS and most Android OS mobile devices.
AliveCors 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," company executives said in a statement.
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, the company says 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, 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 cloud-based AliveCor Heart Monitor app is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device is not intended for pediatric use. It is compatible with all iOS and most Android OS mobile devices.
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