The Food and Drug Administration has approved the first mobile medical app that will allow remote monitoring of patient glucose data.
The technology, from medical device firm Dexcom, had been “eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” said Alberto Gutierrez, the FDA's director of the office of in vitro diagnostics and radiological health.
The approval likely has wider regulatory implications for the other medical apps and devices as well, suggested Bradley Thompson, a lawyer with Epstein Becker Green and an expert in mobile health regulations.
The agency approved the app through the so-called “de novo” pathway, which allows companies to face lightened regulatory requirements for novel, yet low- or medium-risk devices or software. That's significant, Thompson said, because the app is acting as an accessory to a high-risk device—a continuous glucose monitoring system.
For developers, that suggests medical accessories and apps will not necessarily be automatically classed as high-risk simply because they accompany or work through high-risk devices. To qualify for such approval, typically a manufacturer or developer has to prove that the submission is similar to an already-approved device.
How broad the FDA's willingness to approve new apps through the de novo pathway will be remains an open question, however.
“Industry remains concerned that this is a relatively inefficient way to deal with a very broad accessory issue where similar technologies might be very low risk but may connect to a different medical device,” Thompson said. “Dexcom had to undertake undoubtedly considerable expense to put together the de novo submission, and my hat is off to Dexcom for basically blazing the way for its direct competitors to follow. Unfortunately, not many companies are so willing to subsidize their competitors.”
The agency also noted, in a news release announcing the approval, the presence of an open-source community, Nightscout, that had pioneered the sharing of data to mobile devices.
Nightscout had been telling patients and their caregivers how to perform the same task with Android devices. The approval might suggest they no longer need to do that.
But some leaders of the community say they'll continue to experiment with new functions and forms. John Costik, a software engineer in Rochester, NY, said that “Nightscout's mission, goal, has always been to lessen the burden of (Type 1 diabetes.)”
Jason Adams, another leader, said he thought the open-source group could take some credit for spurring FDA into approving the app. “We were able to show both the FDA and Dexcom that there is a tremendous unmet patient need. (We) pushed Dexcom to innovate faster, pushed FDA to approve faster.”
Like Costik, Adams thinks the group can do more—perhaps with software for other continuous glucose monitors.
Follow Darius Tahir on Twitter: @dariustahir
