Accelerate FDA regulatory clearances with confidence
RegHero automates key workflows like 510(k) predicate research so you can safely bring new products to market faster
Accelerate FDA regulatory clearances with confidence
RegHero automates key workflows like 510(k) predicate research so you can safely bring new products to market faster
Accelerate FDA regulatory clearances with confidence
RegHero automates key workflows like 510(k) predicate research so you can safely bring new products to market faster
Find your best 510(k) predicate — smart, fast and thoroughly
Smart Predict delivers lightning-fast predicate search results using AI that understands your device — even without exact keywords.
Find your best 510(k) predicate — smart, fast and thoroughly
Smart Predict delivers lightning-fast predicate search results using AI that understands your device — even without exact keywords.
Find your best 510(k) predicate — smart, fast and thoroughly
Smart Predict delivers lightning-fast predicate search results using AI that understands your device — even without exact keywords.
SMART PREDICATE
How it works: AI-powered predicate device discovery
Our machine learning technology understands medical device functionality to find the strongest predicates for your 510(k) submission.
Natural language search
Simply describe your device as you would to a colleague. Our AI understands intended use and technical characteristics.
Intelligent comparison
Review standardized data from each potential predicate to quickly identify which offers the strongest foundation for your submission.
Submission insights
Generate regulatory documentation with properly formatted references to streamline your 510(k) preparation.
SMART PREDICATE
How it works: AI-powered predicate device discovery
Our machine learning technology understands medical device functionality to find the strongest predicates for your 510(k) submission.
Natural language search
Simply describe your device as you would to a colleague. Our AI understands intended use and technical characteristics.
Intelligent comparison
Review standardized data from each potential predicate to quickly identify which offers the strongest foundation for your submission.
Submission insights
Generate regulatory documentation with properly formatted references to streamline your 510(k) preparation.
SMART PREDICATE
How it works: AI-powered predicate device discovery
Natural language search
Simply describe your device as you would to a colleague. Our AI understands intended use and technical characteristics.
Intelligent comparison
Review standardized data from each potential predicate to quickly identify which offers the strongest foundation for your submission.
Submission insights
Generate regulatory documentation with properly formatted references to streamline your 510(k) preparation.
WHY REGHERO
Why RegHero outperforms traditional methods
Regulatory professionals have traditionally relied on limited tools that require extensive manual work. RegHero's specialized AI technology delivers results that conventional methods can't match, saving hours of research time while finding more relevant matches.
Feature
FDA Database
Google Search
AI Assistants
RegHero
Search capabilities
Semantic understanding
Device function matching
Predicate identification
Regulatory filtering
Result organization
Competitive analysis
Market visualization
Predicate mapping
Regulatory insights
Update frequency
Integration
Limited
Limited
Basic
Manual
Limited
Basic
Monthly
Variable
Partial
Text only
Limited
Limited to training data
Interactive
Real-time
WHY REGHERO
Why RegHero outperforms traditional methods
Regulatory professionals have traditionally relied on limited tools that require extensive manual work. RegHero's specialized AI technology delivers results that conventional methods can't match, saving hours of research time while finding more relevant matches.
Feature
FDA Database
Google Search
AI Assistants
RegHero
Search capabilities
Semantic understanding
Device function matching
Predicate identification
Regulatory filtering
Result organization
Competitive analysis
Market visualization
Predicate mapping
Regulatory insights
Update frequency
Integration
Limited
Limited
Basic
Manual
Limited
Basic
Monthly
Variable
Partial
Text only
Limited
Limited to training data
Interactive
Real-time
WHY REGHERO
Why RegHero outperforms traditional methods
FDA Database
Google Search
AI Assistants
RegHero
Semantic understanding
Device function matching
Predicate identification
Regulatory filtering
Result organization
Market visualization
Predicate mapping
Regulatory insights
Update frequency
Integration
FAQ
About RegHero & Free Trial
What is RegHero?
RegHero is an AI-powered platform designed to streamline the FDA 510(k) regulatory process for medical device companies. It helps regulatory professionals automate key workflows, particularly predicate device research, which is critical for getting new medical devices cleared by the FDA.
How can I subscribe?
Subscribing to RegHero is simple and flexible. Just choose the plan that fits your needs and get started.
Sign up online: Pick a plan on our Pricing page and start using RegHero right away.
Free Plan: Try 10 AI-powered predicate searches—no credit card needed.
Cancel anytime: Whether you're testing the waters or just need a break, you can pause or cancel your subscription at any time, no questions asked.
We believe in transparent value—no hidden fees, no surprise charges. Just real tools that help you move faster and smarter through regulatory processes.
Is there a free trial available?
All users receive 10 Smart Predicate Searches—enough to experience how RegHero surfaces relevant devices faster and smarter than traditional methods. No credit card required.
What types of data are available in RegHero?
As of April 2025, RegHero covers 170k+ devices cleared by FDA since 1976, including:
510(k) summaries
Adverse events
Recalls
Clinical information
We extract and structure data such as device metadata, company details, predicates, and regulatory decisions. If you need more, reach out at partnership@reghero.ai—we're constantly expanding.
Not seeing what you need?
Tell us about your use case—we’re here to help.
FAQ
About RegHero & Free Trial
What is RegHero?
RegHero is an AI-powered platform designed to streamline the FDA 510(k) regulatory process for medical device companies. It helps regulatory professionals automate key workflows, particularly predicate device research, which is critical for getting new medical devices cleared by the FDA.
How can I subscribe?
Subscribing to RegHero is simple and flexible. Just choose the plan that fits your needs and get started.
Sign up online: Pick a plan on our Pricing page and start using RegHero right away.
Free Plan: Try 10 AI-powered predicate searches—no credit card needed.
Cancel anytime: Whether you're testing the waters or just need a break, you can pause or cancel your subscription at any time, no questions asked.
We believe in transparent value—no hidden fees, no surprise charges. Just real tools that help you move faster and smarter through regulatory processes.
Is there a free trial available?
All users receive 10 Smart Predicate Searches—enough to experience how RegHero surfaces relevant devices faster and smarter than traditional methods. No credit card required.
What types of data are available in RegHero?
As of April 2025, RegHero covers 170k+ devices cleared by FDA since 1976, including:
510(k) summaries
Adverse events
Recalls
Clinical information
We extract and structure data such as device metadata, company details, predicates, and regulatory decisions. If you need more, reach out at partnership@reghero.ai—we're constantly expanding.
Not seeing what you need?
Tell us about your use case—we’re here to help.
FAQ
About RegHero & Free Trial
What is RegHero?
RegHero is an AI-powered platform designed to streamline the FDA 510(k) regulatory process for medical device companies. It helps regulatory professionals automate key workflows, particularly predicate device research, which is critical for getting new medical devices cleared by the FDA.
How can I subscribe?
Subscribing to RegHero is simple and flexible. Just choose the plan that fits your needs and get started.
Sign up online: Pick a plan on our Pricing page and start using RegHero right away.
Free Plan: Try 10 AI-powered predicate searches—no credit card needed.
Cancel anytime: Whether you're testing the waters or just need a break, you can pause or cancel your subscription at any time, no questions asked.
We believe in transparent value—no hidden fees, no surprise charges. Just real tools that help you move faster and smarter through regulatory processes.
Is there a free trial available?
All users receive 10 Smart Predicate Searches—enough to experience how RegHero surfaces relevant devices faster and smarter than traditional methods. No credit card required.
What types of data are available in RegHero?
As of April 2025, RegHero covers 170k+ devices cleared by FDA since 1976, including:
510(k) summaries
Adverse events
Recalls
Clinical information
We extract and structure data such as device metadata, company details, predicates, and regulatory decisions. If you need more, reach out at partnership@reghero.ai—we're constantly expanding.
Not seeing what you need?
Tell us about your use case—we’re here to help.
PRICING
Choose the right plan
No credit card required for free plan
Free Plan
Essential regulatory search for individuals.
$0
/month
10 AI-powered searches
CSV exports
Professional plan
Complete solution for regulatory teams
$99
/month
100 Monthly AI-powered searches
Competitive analysis
Enterprise plan
Custom solution for MedTech companies and CROs.
Custom
/month
Unlimited search
Data integrations
Dedicated support
PRICING
Choose the right plan
No credit card required for free plan
Free Plan
Essential regulatory search for individuals.
$0
/month
10 AI-powered searches
CSV exports
Professional plan
Complete solution for regulatory teams
$99
/month
100 Monthly AI-powered searches
Competitive analysis
Enterprise plan
Custom solution for MedTech companies and CROs.
Custom
/month
Unlimited search
Data integrations
Dedicated support
PRICING
Choose the right plan
No credit card required for free plan
Free Plan
Essential regulatory search for individuals.
$0
/month
10 AI-powered searches
CSV exports
Professional plan
Complete solution for regulatory teams
$99
/month
100 Monthly AI-powered searches
Competitive analysis
Enterprise plan
Custom solution for MedTech companies and CROs.
Custom
/month
Unlimited search
Data integrations
Dedicated support
Whether you're launching a new Class II device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.
Whether you're launching a new Class II device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.
Whether you're launching a new Class II device or supporting a client submission, RegHero handles the regulatory heavy lifting — fast, accurate, and AI-powered.