Unlike general research tools or static databases, Agent Astro:

• Uses AI to surface patterns and hidden insights
• Is tailored to FDA medical device submissions
• Was built in consultation with regulatory experts
• Offers flexible access—monthly subscriptions, enterprise licenses, or per-query pricing

Agent Astro is built for:

• Regulatory Affairs professionals
• Medical Device developers
• Startups and multinational companies navigating U.S. FDA requirements
• Consultants specializing in FDA submissions

Agent Astro is an AI-powered regulatory intelligence tool designed specifically for medical device companies. We help teams accelerate the FDA approval process by simplifying research, identifying predicate devices, and surfacing key insights from regulatory databases like 510(k), De Novo, and PMA.

Agent Astro helps you:

• Find relevant predicate devices quickly
• Understand past FDA decisions and trends
• Streamline your research and submission prep process
• Save dozens of hours per application
• Reduce your regulatory team’s size and workload

Using publicly available FDA data and proprietary AI workflows, Agent Astro:

1. Compiles and contextualizes device information from FDA databases
2. Highlights approval timelines, submission content, and key decision points
3. Identifies “substantial equivalence” pathways for your device
4. Offers insights that support faster, more confident decision-making

We offer three subscription tiers:

• Starter Tier: Ideal for smaller companies or consultants, with limited queries per month
• Professional Tier: For growing teams needing regular access and deeper reports
• Enterprise Tier: For high-volume users with full access, white-glove support, and optional per-query add-ons

(Note: Pricing and tier details are available upon request or via a demo)

Yes. We offer a trial period so you can explore the platform and see its value firsthand. We also provide discounted pricing during the trial for early adopters.

Agent Astro uses only publicly available regulatory data. No confidential company information is uploaded or stored unless explicitly shared by you. We follow best practices in security, privacy, and data handling.

Yes. We offer per-query pricing for occasional users. Packages of 10 or 20 queries can be purchased separately, making Agent Astro accessible even for smaller projects.

You can request a demo, sign up for a trial, or purchase a query package today. Just visit our Contact page to begin.