FDA approves Dexcom's CGM accessory app days after relevant draft guidance

By Jonah Comstock
08:56 am
The old Dexcom Share, with charging cradle. The old Dexcom Share, with charging cradle.

Dexcom has received approval from the FDA for a new version of its smartphone connected Dexcom Share platform that will eliminate the docking cradle and allow a patient's continuous glucose monitor data to be transferred directly to a user's smartphone, as well as the smartphones of up to five friends or caretakers.

Dexcom Share got clearance in October as a docking cradle that could house the Dexcom G4 CGM receiver. The Dexcom G4 CGM system consists of a 7-day sensor with a needle that rests under the skin and a pocket-sized receiver device that displays the near real-time blood glucose data from the sensor.

The receiver went through a Class III pre-market approval process, Steve Pacelli, Dexcom's EVP of Strategy and Corporate Development, told MobiHealthNews. The apps themselves, which will display the CGM data, were approved through a de novo classification process and then down-classified to a Class II device exempt from premarket clearances. That means other companies' future applications that display CGM data -- while not claiming to be the primary readout of that data -- will be able to get through the FDA just by registering.

For Dexcom customers, the newly approved technology will allow patients to track and transmit their blood glucose data on the move, whereas the cradle was only useful in situations where the user would be in one place long enough to plug the device into the wall.

"With this functionality, parents would be able to have realtime access to a child’s data really at any time," Pacelli told MobiHealthNews. "If there was a problem, for example a hypoglycemic episode, you would be notified, and whoever was responsible at the kid’s school -- the school nurse or the teacher -- would also receive an alert. That’s obviously the prime example. I think also we see applicability for spouses who travel or adults caring for the elderly. You wouldn’t have to check their blood sugar every day because you'd have access and you'd know their blood sugar is OK."

Dexcom anticipates beginning to ship the new receiver in early March. The company is gifting the upgrade to all patients who purchased the cradle, and will also offer a discount to G4 CGM users who don't have a cradle.

Bradley Merrill Thompson, a partner at Epstein Becker Green, says that the down classification of Dexcom's smartphone apps is a significant move, as it follows closely on the FDA's proposal in its new draft guidance that it would do just that. Even though the CGM remains a Class III device, apps that serve as an accessory to a CGM will no longer need to go through a class III process, thanks to Dexcom.

"This is indeed confirmation that FDA was serious in its accessories guidance in saying that it would be willing to down classify low risk accessories in response to a de novo request," he wrote in an email to MobiHealthNews. "While there may only be a few companies that are interested in this particular technology, the FDA's action displays a much broader willingness to treat accessories reasonably."

So far, Dexcom is without competition in the smartphone-connected CGM business, but Medtronic announced something similar, its Guardian Mobile platform, back in September. There's been no word on it since, but Dexcom's FDA approval here may have helped pave the way for a smoother regulatory process for Medtronic. Thompson suggests this might point to a problem with the FDA's new strategy.

"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," Thompson wrote. "Unfortunately, not many companies are so willing to subsidize their competitors."


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