AliveCor has received an additional FDA 510(k) clearance, this time for an algorithm that allows its smartphone ECG to detect atrial fibrillation — an abnormal heart rhythm that isn’t always detectable to the patient, but if left untreated can lead to stroke or congestive heart failure — with high accuracy. The app is set to launch for consumers in September.
“Our pretty strong belief is that if people did this, if they got the app and used it regularly, especially in the at risk population of people over 40, that they will catch atrial fibrillation that was previously undiagnosed, using a mobile technology,” Euan Thomson, president and chief executive officer of AliveCor, told MobiHealthNews. “It’s got great value to patients. From a conceptual standpoint or from a mobile helath perspective, I think we’re really delivering on the promise of mobile health in a very meaningful way.”
AliveCor’s smartphone ECG, which is available for both Apple and Android phones, has had FDA clearance since last fall and has been in use by patients since March. But up until now, consumers using the device would simply send their ECG readings to a board-certified cardiologist or cardiac technician, who would turn a response around in 24 hours — or faster for a small fee. Keep reading>>