AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate Feedback
San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and its accompanying AliveECG app.
The press release states that:
AliveCor’s 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.
According to the press release, these algorithms are designed to provide immediate notification to patients, which allows them to alleviate anxiety over arrhythmias when they are reassured that their ECG is normal, and allows for the delivery of more efficient care and follow-up by allowing healthcare providers to focus on reviewing ECGs that are the most concerning.
The press release further states that the AliveCor Heat Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health conscious individuals in order to record, store and transfer single-channel ECG rhythms. AliveCor’s website notes that the AliveCor Heart Monitor and its accompanying AliveECG app are compatible with all iOS and most Android OS mobile devices.
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