The meter and pump can seamlessly transmit data back and forth via Bluetooth, allowing for remote insulin delivery and providing guidance on dosage levels.
"With this clearance we are now looking forward to launch the 2nd device in the U.S. this year, after the successful clearance of the Accu-Chek Nano SmartView system in the 1st quarter," chief operating officer Daniel O’Day said in prepared remarks. "Both launches represent a significant milestone for our diabetes care business."
The Combo system is already on the market in several European and Asia-Pacific countries, including France, Germany, the U.K. and Australia.
The device also features a full-color display and an insulin cartridge that holds up to 315 units of insulin, which the company says is the largest capacity among pumps sold in the U.S.