The Problem: Regulatory Research is Broken

Over hundreds of conversations with regulatory experts, MedTech founders, and R&D teams, one thing became obvious: navigating the FDA’s databases is a time-consuming, manual process.

Whether you're looking for a predicate device, understanding a previous decision, or building your submission strategy, the information is technically public — but practically inaccessible.

• You spend hours sifting through outdated PDFs
• You rely on institutional memory or fragmented spreadsheets
• You duplicate work that’s already been done by someone else

This isn’t just inefficient — it’s a bottleneck that holds the entire industry back.

The Insight: The Playbook Already Exists

The FDA publishes tens of thousands of decisions, classifications, and summaries. The playbook is out there — it’s just not designed to be usable. We realised there was an opportunity to unlock this wealth of public information and make it work for regulatory professionals, not against them.

The Solution: Smarter Predicate Identification with Agent Astro

Agent Astro uses Retrieval-Augmented Generation (RAG) to bring together advanced AI and verified source retrieval. It’s not guessing or hallucinating — it’s surfacing real precedents and helping you build a stronger case, faster.

Our mission is clear:

Empowering regulatory professionals with smarter predicate identification tools.

We’re focused on solving one of the most costly and overlooked problems in MedTech: the wasted time spent reinventing the wheel during every submission.

Stage 1: FDA Data (Raw)

What's Included

- Public summaries
- Classifications
- Review memos

Stage 2: AI Processing

What's Included

- RAG (Retrieval-Augmented Generation)
- Search
- Indexing

Stage 3: Output

What's Included
- Predicate recommendations
- Justification language
- Faster planning

Why It Matters

Small and mid-sized medical device companies often don’t have large regulatory teams or expensive consultants. Agent Astro levels the playing field by giving them access to the same strategic insights — faster, more reliably, and with less effort.

And for larger companies, it’s about scaling smarter. Reducing research time, improving team efficiency, and bringing more products to market — sooner.

Our Commitment: Security, Precision, Transparency

Regulatory affairs demand trust. That’s why we’ve built Agent Astro to meet the highest standards in data security and explainability. You’ll always know where a result came from, what it’s based on, and how to use it confidently.

Looking Ahead

We believe regulatory affairs should be a strategic advantage, not a barrier. If you’re ready to stop wasting time on repetitive research and start building submissions with precision and speed, we built Agent Astro for you.