Opinion: Using Non-FDA-Approved Diabetes Software Changed My Life

A patient shares their experience managing diabetes with software that hasn't received FDA approval, reporting significant improvements in their health outcomes. The commentary raises important questions about regulatory processes for digital health tools, noting that traditional FDA review timelines may not keep pace with rapid software innovation. Expert Dana Goldman argues the FDA needs to evolve its approach to evaluating digital health solutions rather than simply accelerating existing review methods. This perspective highlights the growing gap between technological advancement and regulatory frameworks in managing chronic diseases like diabetes. The discussion underscores the need for balanced approaches that enable innovation while maintaining patient safety standards.