Streamline your Approval and Get Started

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AI‑Powered
Regulatory Intelligence

Accelerate FDA 510(k) submissions with faster predicate searches and submission-ready reporting.

Approval Process

Core Advantages

Predicate Intelligence

Identify the right predicate devices in seconds, not months.

Submission-Ready Reporting

Generate structured reports aligned with FDA expectations.

Compliance Confidence

Build on secure, validated data you can trust.

Meet AgentAstro

AgentAstro helps regulatory teams cut months of work into hours by combining FDA data with AI-powered analysis.

  • Use it to accelerate 510(k) submissions.
  • Strengthen compliance strategies.
  • Uncover Insights on predicate devices.
  • All services in one secure platform.

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AgentAstro

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Hi there! I'm AgentAstro.AI – the AI that simplifies FDA 510(k) approvals. How can I help you today?

How It Works ?

Transform your regulatory workflow with our intelligent process.

1

Ask Questions

Use plain language for your toughest regulatory queries.

2

Identify Predicate Devices

Instantly access and analyze FDA data.

3

Compare Details

Review specs, testing protocols, and pathways side by side.

4

Market Insights

Track regulatory updates, trends, and risks.

Ready to streamline your FDA submissions?

Connect with Us

What do our Users are Saying

"Agent Astro represents the next evolution of regulatory affairs: Combining AI powered industry expertise for faster approvals."
"Agent Astro’s insights empower teams to navigate submissions with confidence, saving time and resources across operations."
"As a subscriber,Agent Astro is a promising tool that speeds up and improves confidence in regulatory submissions."
"Agent Astro represents the next evolution of regulatory affairs: Combining AI powered industry expertise for faster approvals."
"Agent Astro’s insights empower teams to navigate submissions with confidence, saving time and resources across operations."
"As a subscriber,Agent Astro is a promising tool that speeds up and improves confidence in regulatory submissions."
"Agent Astro gave us valuable insights into the FDA 510(k) process and regulatory requirements."
"We’ve reduced unnecessary costs since adopting AgentAstro.ai—the platform’s ability to identify optimal solutions."
"The customizability and integration capabilities of this app are top-notch."
"Agent Astro gave us valuable insights into the FDA 510(k) process and regulatory requirements."
"We’ve reduced unnecessary costs since adopting AgentAstro.ai—the platform’s ability to identify optimal solutions."
"The customizability and integration capabilities of this app are top-notch."