Over the past year, I’ve had a front-row seat to one of the most expensive, and time-consuming challenges in healthcare innovation: navigating the regulatory pathway for medical devices.
At Rise Up Strategies, we work with mission-driven leaders and high-impact ventures. Again and again, I kept hearing the same pain point—particularly from medtech founders and regulatory professionals: preparing a 510(k) submission for the U.S. FDA is a bottleneck that eats up months of time, demands huge internal resources, and introduces massive uncertainty.
It’s not just a documentation problem. It’s a research problem. A strategy problem. A bandwidth problem. Most of all, it’s an insight problem.
So we built Agent Astro.
Agent Astro is an AI-powered platform that accelerates regulatory strategy by helping users identify predicate devices faster, analyse decision-making patterns in past FDA submissions, and develop stronger, more defensible applications. What used to take hours or even days of manual research, can now be done in seconds.
Our early testers include leaders at Baylis Medical Technologies—whose Executive Chairman, Frank Baylis, called it “a game changer for any company preparing a 510(k).”
But Agent Astro isn’t just about speed. It’s about transforming how regulatory professionals think. For example: companies often struggle to argue for lower burdens of proof (e.g. fewer scans, fewer patients, shorter studies) unless they know the precedents. Agent Astro surfaces those precedents—quickly and clearly—by finding patterns in past approvals, even if they’re buried across thousands of pages.
And thanks to RAG (retrieval-augmented generation) and a deep integration with FDA databases, Agent Astro doesn’t hallucinate or make up facts. It shows you why it surfaced a specific device, and links you to the original source. That transparency matters.
We’re now rolling out early access with incentives for early adopters and referrers. The goal is simple: cut time, reduce cost, and give small and mid-sized medtech companies an edge in a space where regulatory uncertainty can mean life or death for innovation.
If we want to accelerate healthcare innovation, we can’t afford to let bottlenecks at the regulatory stage keep holding us back.
