Loop, an artificial pancreas system for diabetics, has a long history in terms of its development, but for a brief summary which might be of interest to the HN audience: It began as a home-brew system, built by diabetics who reverse-engineered insulin pump firmware and control software in order to gain control of the devices which keep them alive. If you've heard of OpenAPS or the Nightscout projects, this was born out of the same community. Insulin pumps, until several years ago, could only be configured statically to adjust the insulin dosing amount which keeps a patient's blood sugar values in range. But when paired with a continuous glucose monitor, a "closed-loop" system can be created to attempt to keep sugars in range algorithmically. A group of engineers launched Tidepool, a non-profit, in an attempt to get full regulatory approval for the software which thousands were running on their devices to expand it to a wider audience, and along they way they have been able to get buy-in from insulin pump manufacturers to develop an open and interoperable ecosystem. Now, 4 or so years later, the system has received FDA clearance -- the first of its kind, not created by one specific insulin pump manufacturer or corporation but instead by a group of developers with backing from this non-profit.

Full press release: https://www.businesswire.com/news/home/20230124006085/en/Tid...