AliveCor gets FDA clearance for two new automated detectors

AliveCor gets FDA clearance for two new automated detectors

The U.S. Food and Drug Administration (FDA) has granted AliveCor clearance for two new algorithms, the company has announced.

One algorithm, 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.

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 two new algorithms are expected to be available in the AliveECG app this quarter for customers in the U.S., UK, Ireland, Australia and India.“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,” said Euan Thomson, president and CEO at AliveCor.

The AliveCor Heart Monitor is intended to record, store and transfer single-channel ECG rhythms. It 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 compatible with all iOS and most Android OS mobile devices.

The two new algorithms 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.