The first iOS app to roll up FDA-approved electrocardiogram (ECG) and blood pressure readings in a single display was introduced Thursday by AliveCor. It's the latest example of the increasing importance of health and medical insights in a field dominated by simpler heart rate bands.
AliveCor's Kardia Mobile app pulls data from the $99 Kardia handheld device, which records ECG from your fingertips, and blood pressure data from any Bluetooth wireless blood pressure cuff made by medical device giant Omron.
AliveCor portrays the app as more than just a dual-device information display. "We not only have FDA approval for our physical device, but this app's instant analysis that tells you if we've detected atrial fibrillation is a separate FDA clearance," says Vic Gundotra, AliveCor's CEO and former senior executive at Google and Microsoft. The FDA has clearance authority for consumer medical devices that read ECG or render a potential diagnosis.
"Somebody with high blood pressure has almost twice the risk of stroke than somebody without high blood pressure," wrote Ralph L. Sacco, M.D., professor and chairman of neurology at the University of Miami, in a recent American Heart Association brief. "But someone with atrial fibrillation has more than five times the risk of stroke."
The app user will certainly want an expert opinion of anything suspect. Gundotra says the Kardia app can share data via an emailed PDF or an API that allows electronic medical records systems to pull from it. That doesn't mean all physicians are ready to embrace patient-generated health data when their practices are based on a fee-for-service model billed by the visit and procedure.
While US consumers will have to pay $99 to get the AliveCor Kardia ECG device and its new app, Britain's National Health Service has decided to start paying for it and other medical devices for some patients starting in April 2017.
In addition to their current handheld style ECG device, AliveCor also has one in the form of an Apple Watch band, but it is still pending FDA approval. Similarly, Omron is working on its Project Zero, a blood pressure monitor in the form of a watch that is slated for release later this year.