Dexcom Inc. (NSDQ:DXCM) won de novo approval from the FDA for the 1st U.S. app to wirelessly connect a patient’s blood glucose monitor with up to 5 mobile devices.
Although patients have created open-source versions to accomplish the same thing, the FDA said DexCom’s Share Direct Secondary Displays system is the 1st legally marketed solution. The news sent DXCM shares up more than 5% this morning.
"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 & Radiological Health, said in prepared remarks.
The federal watchdog agency cleared the device using its de novo pathway for novel, low- to moderate-risk medical devices, designating the Share system as a Class II device that’s exempt from the FDA’s most stringent pre-market approval clinical trial requirements. That clears the way for other medtech makers to put similar systems on the market without needing a PMA.
"Exempting devices from pre-market review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers," Gutierrez said.
DexCom said the Share system is designed to display data from the G4 Platinum device using 2 apps, 1 on the patient’s mobile device and the 2nd on another person’s mobile device. The patient can designate "followers" to receive real-time CGM data. The apps work with Apple‘s (NSDQ:AAPL) iPhone or iPod Touch device, the San Diego-based company said, adding that it plans to make the technology available for Google‘s (NSDQ:GOOG) Android-based devices "in the future." The Share receiver is expected to ship in early March, according to a press release.
"The Dexcom Share receiver represents a significant step forward for our company and our mobile strategy, but more importantly, it will provide a huge improvement for people managing their diabetes and for those parents and caregivers who help them each and every day," DexCom president & CEO Kevin Sayer said in a statement. "The FDA understands the importance of this type of innovation and the need to regulate it appropriately, and we could not be more pleased with the speed at which they reviewed and approved this important innovation."
DXCM shares were trading at $60.84 apiece today in late-morning activity, up 5.0%.
