A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars.
Unlike popular fitness-tracking devices, such as Fitbit Inc’s Fitbit and Jawbone’s UP wristbands, these so-called medical-grade wearables require approval from the U.S. Food and Drug Administration - a rigorous regulatory hurdle that first-generation wearables sought to avoid.