Dexcom G7 & APIs
Dexcom (NSDQ:DXCM) Chairman, President & CEO Kevin Sayer told Drug Delivery Business News earlier this year that the company expects to launch its next-generation G7 continuous glucose monitor (CGM) in Europe this autumn. During Dexcom’s third-quarter earnings call this month, he said the company remains on track for a fourth-quarter launch of the G7 following CE mark clearance.
When it comes to the U.S. market and the G7, Sayer expected Dexcom to make a comprehensive 510(k) submission, including G7 hardware and full Android and iOS software, to the FDA in the next few weeks. He said the U.S. clinical trial for the device has concluded.
“It’s been our experience over time when we deliver what the FDA expects, they move very quickly and are very cooperative with us,” Sayer said. “We have no reason to believe the file we’re preparing isn’t going to meet those expectations. We’re moving along those lines. So again, with the CE Mark filing, we’re on track for an [outside of U.S.] launch later this year, and we’ll update you more on the U.S. as time goes on.”
The company also announced last month that Garmin became the company’s first partner for its real-time application programming interfaces (APIs).
Garmin introduced its Dexcom Connect IQ apps on its smartwatch and cycling computer. The Dexcom Partner Web APIs enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices.