The FDA Just Approved the First Artificial Pancreas for Diabetes

by :Sy Mukherjee

It’s slated to hit the market next spring.

The first-ever artificial pancreas for treating diabetes will hit the market in spring of 2017.

Medical device maker Medtronic MDT 0.08% on Wednesday won Food and Drug Administration (FDA) approval of the device, the MiniMed 670G, a “hybrid closed loop system” which largely automates the cumbersome process of monitoring and adjusting type 1 diabetes patients’ glucose and insulin levels.

The MiniMed is comprised of a glucose sensor, an insulin pump, and a program called SmartGuard HCL that Medtronic says is its “most advanced algorithm to date.” The sensor continuously monitors glucose levels and then automatically adjusts how much insulin it delivers so that patients can hit their target blood sugar levels, and a smartphone-like device lets users know what their glucose and insulin metrics are. It essentially serves the role that a healthy pancreas is supposed to address.

“This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said the FDA’s Jeffrey Shuren about the approval.

Medtronic reportedly filed for FDA approval of the MiniMed in June and received regulatory clearance rapidly thanks to the company’s cooperation with the agency.

“Given the earlier-than-anticipated approval and the novel nature of the technology, we plan to begin shipping the MiniMed 670G system in spring of 2017,” said Hooman Hakami, executive vice president at Medtronic Diabetes, in a statement. “This timeline ensures market and manufacturing readiness, payer coverage, and appropriate training of our employees, clinicians, educators, and customers on the new system.”

The system still does require some efforts by patients, who have to refill the insulin and do traditional finger prick tests in order for the device to be work. But the company says it represents a major step towards developing a “a fully automated, closed loop system” that will require even less patient input and effort.

 

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