Idea to Submission: an insulin app from source code to US regulatory pathway

Idea to Submission: the future of developing a medical device. We started with nothing but the source code of AndroidAPS, an open-source insulin-dosing app, and asked: how far can one conversation in Clareo take it? What you'll see (sped up from the real run): • Claude Code reads the codebase and proposes safety requirements traced to the implementation • Business model: Lean Canvas and Healthcare Canvas • State-of-the-art literature review: search, grading, synthesis • US regulatory pathway: product code, predicate and determination, with the evidence linked • Quality system: user needs and system requirements, traced and audited The founder signs off every decision a regulator will hold them to. Early access for MedTech founders: https://app.clareoai.com/signup?utm_s... Website: https://clareoai.com Demo built on AndroidAPS by its open-source community (github.com/nightscout/AndroidAPS, AGPL-3.0). Thank you for the work that made this possible. AndroidAPS is not affiliated with Clareo and is not a cleared device. Regulatory output is decision support, not regulatory advice.