AgentAstro is an AI - powered regulatory intelligence platform purpose - built for the MedTech industry.It accelerates the FDA 510(k) process while also supporting upstream activities such as materials selection, design considerations, and early product strategy.

By combining FDA data with a wide range of trusted industry and scientific sources , AgentAstro provides a complete view of regulatory precedent, design implications, and market context.

Instead of free - form text, it produces submission - ready outputs tailored to FDA expectations, while giving teams the intelligence they need to design smarter and plan more strategically.

In short: AgentAstro is both a regulatory assistant and a strategic intelligence tool, helping MedTech companies move faster from concept to clearance.

AgentAstro is built from the ground up for FDA medical device submissions—with data protection as our top priority.

1. Your proprietary data stays yours. Files you upload are encrypted, isolated, and never shared. Unlike general LLMs, your data is never used to train outside models or exposed to other users.

2. Purpose-built for 510(k) submissions. Where general AI tools generate free-form text, AgentAstro produces submission-ready outputs aligned with FDA expectations.

3. Direct FDA integration. AgentAstro continuously pulls from FDA's public databases to surface predicates, timelines, and review decisions—data that general LLMs don't reliably provide.

4. Specialized AI collaboration. Instead of one generic model, AgentAstro uses multiple AIs, each tuned for regulatory tasks, to deliver the most accurate results.

5. Team-ready. Designed for regulatory teams to collaborate in one workspace with shared insights and outputs.

6. Intuitive and built-to-purpose. No prompt-hacking required—professionals can focus on strategy, not workarounds.

7. Expert-informed. Developed alongside regulatory affairs leaders to reflect real-world FDA practice.

In short: AgentAstro keeps your data secure and delivers FDA-ready outputs—something general LLMs can't match.

General-purpose AI tools like ChatGPT can generate text, but they are not designed for regulatory submissions. AgentAstro is purpose-built for MedTech, with advantages that generic AI cannot match:

In short: ChatGPT can write, but AgentAstro can help you clear the FDA.

AgentAstro is designed for MedTech teams at every stage of development, not only during submission prep. It supports:

In short: AgentAstro is for anyone in MedTech who wants to design smarter, move faster, and submit with confidence.

The FDA 510(k) process is complex, slow, and resource-intensive. AgentAstro transforms how MedTech teams approach it by:

In short: AgentAstro makes FDA submissions faster, stronger, and more efficient by an order of magnitude—helping MedTech companies design smarter and clear the FDA with confidence.

AgentAstro combines FDA databases with advanced AI workflows to deliver 10x gains in efficiency and effectiveness.

In short: AgentAstro transforms raw FDA data into secure, submission-ready intelligence—giving MedTech teams an order-of-magnitude advantage over manual work or general AI tools.

AgentAstro is the product of a unique collaboration between MedTech veterans, regulatory professionals, and AI engineers. The idea grew out of a pressing reality: medical device companies spend enormous amounts of time and resources navigating the FDA 510(k) process, yet the tools available to them are either too generic or too risky to trust with sensitive information.

General-purpose AI tools can't guarantee that proprietary data stays private, and many companies are rightly concerned that confidential files might be exposed or reused to train outside models. AgentAstro was designed to solve this problem from the ground up. Proprietary data is always encrypted, isolated, and never used to train external systems—ensuring companies can take advantage of AI without sacrificing security.

Our MedTech advisors bring firsthand experience launching devices and managing the pressures of FDA clearance. Our regulatory professionals ensure that every output reflects real-world submission practices and aligns with FDA expectations. And our AI engineers translate that expertise into secure, specialized workflows that go far beyond what general-purpose AI tools can deliver.

The result is AgentAstro: a platform built at the intersection of regulatory expertise and AI innovation, designed to make the FDA process faster, smarter, and more secure.

AgentAstro offers three subscription tiers designed to fit different needs:

Plans are available on a monthly or annual basis.

In short: whether you’re a solo consultant, a growing team, or a global enterprise, AgentAstro offers a plan built to match your scale and workflow.

Getting started with AgentAstro is simple:

In short: book a demo, pick a plan, and start accelerating your FDA submissions.