AGENTASTRO.AI

Fast Track Your FDA 510(k) Approval with AI-Powered Precision

AgentAstro makes your 510(k) process smarter and faster by automating time-consuming searches for predicate devices. Our proprietary AI agent will help you reduce costs and delays by spotting chances to skip unnecessary testing.

Smarter Submissions, Faster Approvals — Powered by AgentAstro.ai.

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How It Works

Ask complex regulatory questions using natural language—no advanced search skills required. Instantly access and analyse FDA 510(k) data to uncover relevant predicate devices. Compare device specs, testing protocols, and regulatory pathways side by side. G...

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Key Benefits

Accelerate your 510(k) process by automating time-consuming predicate searches.Build a stronger case with data-backed insights that enhance your FDA submissions.Reduce costs and delays by identifying opportunities to avoid unnecessary testing.

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Platform Features

Advanced Predicate Search

Search the FDA’s 510(k) database using intuitive, natural language prompts—no complex filters or keyword guesswork.→ Find the most relevant predicates in seconds.
Detailed Regulatory Reporting

Generate expert-level reports that compile and contextualise FDA data to support your substantial equivalence narrative.→ Strengthen your submission with clear, defensible documentation.
Secure Data Management

All user activity and file transfers are protected with industry-standard encryption.• In-Transit: SSL/TLS encryption safeguards all communications.• At-Rest: AES-256 encryption secures stored data and files.→ Enterprise-grade protection for sensitive info...
Compliance-Ready Architecture

Engineered to align with FDA guidelines and meet HIPAA and GDPR requirements.→ Confidence in every query and report.
Predicate Device Comparison

Easily compare device specs, testing protocols, and regulatory pathways—side by side, in one view.→ Spot differences, justify similarities, and make faster decisions.

Testimonials

What Agent Astro is building is exactly what the medtech industry needs. The ability to rapidly identify predicate devices and learn from past FDA decisions is a game changer for any company preparing a 510(k) submission. This platform has the potential to drastically streamline the regulatory process and lower barriers to innovation.

Frank Baylis

Executive Chairman, Baylis Medical Technologies

About Us

Our Mission
Empowering regulatory professionals with smarter predicate identification tools.

Technology
Harnessing Retrieval-Augmented Generation (RAG) for precise, AI-driven regulatory insights.

Commitment to Security
Built with state-of-the-art encryption and guardrails to ensure compliance and user confidence.

Reach out directly for assistance or feedback:
info [@] agentastro.ai

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