A Historic FDA Clearance: Open Source Software and the Making of Tidepool Loop

Tidepool Loop is the first fully interoperable, open source diabetes technology to achieve FDA clearance. Through an anthropological look inside the making of Tidepool Loop, this chapter offers a primer on the meaning and use of open source in diabetes technology and explores open source as a potential solution to key challenges facing people with diabetes, clinicians, and regulators in the contemporary era of software development.