FDA approves Medtronic's 'artificial pancreas' that monitors glucose, delivers insulin
Medtronic has received approval from the U.S. Food and Drug Administration (FDA) for a potentially revolutionary device that monitors glucose levels and delivers insulin automatically.
The MiniMed 670G works as an “artificial pancreas," because its sensors constantly monitor insulin levels within the body and inject the dose needed accordingly. According to Jeffrey Shuren, MD, JD, director of the FDA's medical device division, the device gives diabetic sufferers "greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin."
"This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time," said Derek Rapp, CEO of the Juvenile Diabetes Research Foundation, who have invested $116 million in artificial pancreas research. "It is a major news event that a system of this kind has been approved—the first time a pump will administer insulin as a result of information it receives from a sensor.”
The device has a sensor the size of a coin with a needle positioned under the skin to monitor glucose levels every five minutes. Paired with an insulin pump, with tubes in a catheter to deliver insulin, the device is the first to have the communication between sensor and pump that automatically provides insulin as needed. The only time patients have to interact with the device to deliver extra insulin is after meals and during exercise.
The FDA has branded the MiniMed 670G as a first-of-its-kind technology for type 1 diabetics and provided approval six months earlier than expected. The devices will be available in the spring of 2017.