As the article points out, there's another OSS solution, Loop (an iOS app with a hardware dongle that talks to a few kinds of pumps), that a company is putting through the FDA approval process (https://www.tidepool.org/loop). This seems like OSS working as intended, would be awesome to have the choice of a fast-moving DIY solution (for techies, early adopters, people without insurance) or a warrantied supported option (for everyone else).