Medical device maker Medtronic Plc, based in Minneapolis, has reportedly filed for regulatory approval with the Food and Drug Administration (FDA) for its artificial pancreas named the MiniMed 670G.
The device is “the size of a smartphone that wirelessly connects an insulin pump and glucose monitor,”wrote Bloomberg.
MiniMed 670G would be stationed outside a user’s body where it can take over for a malfunctioning organ that isn’t naturally producing insulin. It would automatically gauge blood sugar levels every five minutes and determine the best insulin dose to administer so patients stay within their target ranges.
Medtronic’s application to the FDA featured data from more than six months in which 124 patients used the device to manage their disease about 84 percent of the time, according to Bloomberg.
The patients participating in this study had an average blood sugar level of 7.4, but the machine was able to lower these levels to an average of 6.9 with no reports of adverse side effects or technical malfunctions. The hope is that the MiniMed 670G could eliminate the expensive, time-consuming process for managing glucose levels.
Diabetics have to commit to a regular schedule of monitoring their blood sugar and take insulin injections to counteract excessive levels of this hormone so they can hit their ideal target levels, wrote Fortune.
Although the MiniMed 670G automates most of the process, patients still need to perform basic maintenance functions like refilling the insulin pump and doing a finger-prick test every 12 hours.
No deadline has been set for when the FDA will meet to discuss these results. Medtronic, however, expects the agency to make a decision within the next year.