Built for MedTech regulatory teams
The Regulatory Intelligence Platform for Better MedTech Decisions
Agent Astro connects evidence, organizational knowledge, and regulatory context across the product lifecycle.
What predicates fit our wearable cardiac monitor?
- Scanning FDA guidance
- Consulting the device database
- Checking recalls
Grounded answer
Twelve cleared devices share your indications for use. The strongest predicate candidates sit in product code DQA - two carry recent postmarket signals worth reviewing before you commit.
Every claim cited
Run Predicate Investigation · ~2 min
Find similar cleared devices across the FDA record
- Keyword
- Semantic
- IFU phrasing
- Fused into one ranking
1Predicate A
0.94
IFU aligned
2Predicate B
0.81
Clean postmarket
3Predicate C
0.67
Older tech match
177,000+ device records searched
Trace the predicate lineage for our subject device
Ancestry walked, depth by depth
Fragility flags raised
Which regulatory pathway fits our device profile?
- Device profile scored
- Precedent weighed
- Timelines estimated
510(k)
88
De Novo
56
PMA
34
Pathway: 510(k) recommended
Evidence plan drafted
What changes if we add AI/ML to the device?
Base device
+ AI/ML variant
Software documentation
+ IEC 62304 basic
Predicate pool
− 3 candidates
Sterility burden
unchanged
What moves the needle, ranked
Draft the eSTAR for our 510(k)
Device Description
Predicates & Substantial Equivalence
Performance Testing
Software & Cybersecurity
RTA pre-flight
Pre-flight 92/100
2 gaps caught, resolved
Export pre-filled eSTAR PDF
Our clients
Some of the companies we work with.
The evidence base
Every answer is grounded in the public record - cleared devices, recalls, adverse events, and guidance - alongside your own organizational knowledge.
177,000+
FDA device records indexed
93,000+
Structured submission extractions
58,000+
Recall records tracked
2,700+
FDA guidance documents
Core advantages
Four capabilities, one platform
Evidence
Connect regulatory precedent, standards, guidance documents, clinical evidence, and market intelligence in one place.
Context
Understand relationships, implications, risks, and strategic considerations before making critical decisions.
Organizational Knowledge
Preserve and build on knowledge across projects, products, submissions, teams, and years of experience.
Structured Outputs
Generate traceable outputs that support planning, submissions, product development, quality, and commercialization.
Astro Intelligence
Ask in plain language. Confirm before anything heavy runs.
The copilot answers quick questions itself - device records, similar clearances, recalls, applicable guidance. When a question deserves a deeper engine, it proposes the run with an editable scope and a time estimate, and the finished report docks beside the conversation.
The engines
What runs under every answer
Deep Search
Keyword, semantic, and indications-for-use retrievals fuse into one ranking.
Predicate Lineage
The clearance record is a graph. Walk it, generation by generation.
Scenario Compare
Subject and predicates, side by side - the difference that matters, found.
Regulatory Pathway
Candidate pathways scored against your device profile, with the reasons shown.
eSTAR Builder
Sections draft, gaps surface, the pre-flight passes - then the workbook exports.
Regulatory Monitor
Daily checks of the FDA feeds. Quiet days stay quiet; changes surface.
Meet Agent Astro
Fragmented regulatory information, made decision-ready
Agent Astro helps MedTech organizations turn fragmented regulatory information into decision-ready intelligence.
Connect the evidence
Regulatory precedent, standards, guidance documents, clinical evidence, market intelligence, and institutional knowledge, connected so teams can evaluate options and understand implications.
Evaluate the options
Assess pathways, compare devices, explore predicates, and evaluate requirements.
Preserve what you learn
Prepare structured outputs and preserve knowledge across projects and teams, in a platform designed for the complexity of MedTech decision-making.
Product tour
See Agent Astro in action
How teams explore evidence, compare options, and generate structured outputs.
The 2026 Benchmark Report
Benchmarked against frontier LLMs. Measured, not claimed.
A reproducible, like-for-like evaluation on FDA 510(k) predicate discovery and regulatory question answering - against Gemini, GPT-5.5 and 5.6, Claude, Grok, Kimi, and Perplexity, each with and without web search.
- 0Fabricated clearance numbers
Across every task in the report.
- 100%Recall counts exactly right
The best web-enabled model manages 73%.
- 90 / 90Accurate and calibrated
The only system strong on both, on regulatory Q&A.
Predicate discovery from a description alone
Hit@10 · 200 devices cleared after the models’ training cutoffs
Agent Astrozero fabricated citations
67.5%
Best frontier model, no webinvents 16–24% of cited K-numbers
2.0%
The task a team actually faces: a device still in development has no published filing to look up. Full methodology, every system, and the results where baselines win - in the report.
From question to submission
One thread, carried end to end
Investigate predicates, weigh the pathway, draft the eSTAR, and catch the gaps before submission - each step grounded in the one before it.
Predicate
Lineage mapped
Pathway
510(k) recommended
eSTAR draft
Sections in order
Submission-ready
Pre-flight passed
How it works
From scattered information to decision-ready regulatory intelligence
- 01
Explore complex questions
Use natural language to investigate regulatory, clinical, quality, and product-related questions.
- 02
Connect relevant evidence
Bring together regulatory precedent, standards, guidance documents, submissions, and organizational memory.
- 03
Understand context
Evaluate similarities, differences, risks, testing implications, requirements, and strategic considerations.
- 04
Support better decisions
Generate structured outputs that help teams support, defend, and execute critical decisions.
Ready to make better MedTech decisions?
See how Agent Astro helps teams connect evidence, context, and internal intelligence across the product lifecycle.
Testimonials
Trusted by regulatory, quality, and MedTech leaders
“What Agent Astro is building is exactly what the MedTech industry needs. This platform has the potential to streamline regulatory work and lower barriers to innovation.”
Frank Baylis
Executive Chairman, Baylis Medical
“I was amazed because Agent Astro brought up a predicate that we had not considered. I could clearly see the value.”
“As a subscriber, Agent Astro is a promising tool that improves confidence in regulatory submissions and helps teams work more effectively.”
“Agent Astro represents the next evolution of regulatory affairs, combining Regulatory Intelligence with industry expertise to support better MedTech decisions.”
“Agent Astro shows how AI can move regulatory affairs upstream, helping shape design choices, materials, and supply chain decisions from day one.”
“Agent Astro’s insights help teams navigate submissions with confidence while saving time and resources across operations.”
“Agent Astro gave us valuable insights into the FDA 510(k) process and regulatory requirements.”
“Something inside me tells me that your product has an incredible potential.”
“It has saved us a ridiculous amount of time, I have to say.”