SAN FRANCISCO — For a growing U.S. aging population, tracking heart health via a smartphone can mean the difference between life and death.
This week, two Silicon Valley startups received a green-light from the U.S. Food and Drug Administration for mobile applications that monitor patients from home, a step forward for a nascent digital health industry that has pressed for more clarity from the agency on regulations.
AliveCor said it received the FDA’s approval to detect serious heart conditions in electrocardiogram, or ECG, readings taken from a mobile device. The company says its newly approved algorithm can detect atrial fibrillation, a form of cardiac arrhythmia that affects about one in four adults over age 40.
If its smartphone-compatible heart-monitor device detects an abnormality, a physician could intervene before the patient experiences a stroke or other life-threatening event. The device fits most smartphones and rests on a patient's finger or chest to record an ECG.
“Atrial fibrillation is very hard to identify,” said Euan Thomson, AliveCor's chief executive. “A large group of people have it, but don’t know they have it.”
Mr. Thomson said AliveCor can detect the condition and send the data to a cardiologist for review. The company plans to incorporate this algorithm into its application and make it available to consumers by September.
In addition, startup Vital Connect received approval for a patch — the “HealthPatch MD” — that patients can attach to one of three areas on their chest and view their own biometric data on a mobile device. Sensors embedded in the Band-aid-sized patch track heart rate, pulse variability, respiratory rate, skin temperature, steps, “fall” detection and more.