The Food and Drug Administration granted regulatory approval to medical device maker Medtronic’s artificial pancreas on Wednesday.
Medtronic’s device, named the MiniMed 670G, is known as a “hybrid closed loop system.” It essentially automates the laborious process needed to check glucose and insulin levels in type 1 diabetes patients.
“The FDA approval of the world’s first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes,” said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic in a statement.
The MiniMed is comprised of a glucose sensor and insulin pump. It gets strapped to a patient’s body where it can be worn by a patient for seven days at a time. The device administers insulin through a catheter while an algorithm powers the sensor to continuously monitor baseline glucose levels, according to FierceBiotech.
A smartphone-like apparatus will let users know where there glucose and insulin levels are at, but patients will still need to do some basic maintenance on the device like refilling the insulin in the pump.
The FDA’s approval is indicated for users aged 14 or older diagnosed with type 1 diabetes. It will hit the market sometime next spring.
