The first FDA clearance for the detection of a serious heart condition via a mobile ECG was announced yesterday. AliveCor got the nod for the AF Detector algorithm to detect atrial fibrillation (a warning sign of stroke and heart failure), and next month it plans to incorporate the new ability into its AliveCor smartphone plug-in and app for monitoring the heart.
“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,” CEO Euan Thomson told MobiHealthNews.
Previously, atrial fibrillation could be detected if a user sent his AliveCor Heart Monitor readings to a cardiologist for analysis, but now the algorithm can tell people if they have the condition. The patient can then confirm his or her results from a U.S. board-certified cardiologist or a personal physician via AliveCor’s ECG analysis service. Thomson told MobiHealthNews the device does not produce false negatives and returns a false positive about 3% of the time.
AliveCor’s device is a mobile ECG that snaps onto the back of a smartphone, taking wireless single-lead recordings of heart rhythms, saving readings on the phone and uploading data to a cloud-based server accessible to patients and doctors. The device received clearance in 2012 and is compatible with the iPhone, iPad and Android-based devices.
Thanks to an over-the-counter clearance in February, the heart monitor can be purchased over the counter for $199. Thomson told Tech Page One that over the counter use accounts for about two-thirds of all sales. In addition, the device is used by veterinarians to monitor animals.
More innovations are on the way. According to MobiHealthNews, Thomson said, “We’d like to move toward gathering information about the patients’ environments and recent history and see if we can spot correlations between unusual features and what’s going on in the patient’s life. But that’s where we’re headed: more clinical conditions, more detailed analysis of the ECG itself, and the context of the ECG and what we can learn from that as well.”
Improvements to the device are essential or else the company may be eaten by its product’s host. Earlier this year Apple ($AAPL) filed a patent for an embedded ECG that could eliminate the need for AliveCor’s snap-on accessory. Apple doesn’t cite healthcare uses for the patent in the filing though, instead focusing on the sensor’s uses as a form biometric identification or to possibly read the user’s mood.
The obvious omission in the patent filing is a due to regulatory concerns. Barriers imposed by the FDA have frustrated Silicon Valley big wigs Apple and Google ($GOOG). And that makes AliveCor’s clearance all the more significant.