FDA approval came six months earlier than expected for a Medtronic device that takes on some functions of a pancreas.
“This is a huge deal for our business and, most importantly, for our patients,” said Jeff Hubauer, vice president and general manager of Medtronic’s insulin delivery business, in an interview with the Star Tribune
The device, called the MiniMed 530G, combines an insulin pump with a sensor that halts insulin delivery for two hours if a patient's blood sugar falls below preset levels. An artificial pancreas would adjust insulin delivery continuously as glucose levels change, according to the Pioneer Press.
The approval is expected to help Fridley-based Medtronic come back from three quarters of sales growth decline in its U.S. diabetes division. The device is expected to come online in the next few weeks, according to Bloomberg.
More than a million people with Type I diabetes use continuous glucose monitors, and the number should grow as improvements lead to better control, according to a New-York based advocacy group called JDRF.