Using the company's smartphone app, the patient can then designate "followers" with whom to share their information. The app then receives real-time data and transmits it to an Internet-based storage location, where the follower can also download and view the information via the app. While other similar app systems exist, Friday's approval marks the first of its kind since the FDA started regulating certain medical apps as devices in the fall of 2013.
"This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely," Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a statement.
The FDA's marketing approval for Dexcom's system could pave the way for similar technologies. Because the app was approved as a "low- to moderate-risk" medical device, other manufacturers that want to market a similar app in the future won't need to receive prior clearance from the agency. They will, however, have to register their product with the FDA.
The agency has made clear that it does not intend to crack down on the majority of health-related mobile apps -- of which there are thousands, because most pose little risk to consumers. But in its 2013 guidance, the FDA said it would regulate a subset of mobile apps "that present a greater risk to patients if they do not work as intended."