FDA Approves First-Ever Artificial Pancreas for Commercial Sale
The Medtronic 670G will be sold commercially in the spring of 2017.
Ladies and gentlemen, the future is now.
The FDA released a press release that matter-of-factly announced what once sounded like science fiction has now become science. Mark it down that on September 28, 2016, the first artificial pancreas system gained approval for commercial sale in the United States.
The device in question is Medtronic’s 670G hybrid automated system, a single-chamber integrated pump and CGM system that automatically adjusts insulin levels based on glucose readings. Federal regulators approved the system after examining data from a trial of 123 participants using the 670G for three months in a real-world setting. During that time, there were no episodes of several hypoglycemia or ketoacidosis. That’s zero, zip, none.
The 670G is now approved for people with Type 1 diabetes ages 14 and older. The FDA announcement said that Medtronic is currently conducting clinical studies to evaluate the safety and effectiveness of the 670G for younger children (ages 7 to 13.) with Type 1 diabetes. The agency will also require Medtronic to do further testing to gather data on the 670G in real world settings. Medtronic announced it would begin commercial release of the 670G in the Spring of 2017.
Here we could give you a lot of carefully crafted quotes from the press releases from Medtronic and the FDA, but none of the words would do justice to the raw emotion people who have fought for years for such a system will feel with this news. For every parent who Google-searched desperately for a better treatment option in the aftermath of a child’s scary low; to every Type 1 activist who pushed the FDA to move faster; to every Type 1 hacker who would not wait and decided to code a DIY artificial pancreas just to show it’s possible, this is a moment of bittersweet victory.
Soon, this elation will give away to scrutiny, impatience, and the inevitable disappointment that comes from chasing after a pot of gold. After all, an artificial pancreas is not a magic wand, and it certainly is not a cure. But for now, let us savor this moment.
A hybrid closed-loop system has been approved. I just wanted to write that again, because it feels so damn good to read it.
6/28/2016 – An earlier version of this article described the pump a “closed-loop” system. After the editor caught his breath from the news, he realized the term might be better reserved for a dual-chamber pump system that includes glucagon.
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