Accelerate your FDA submission preparation

Find Predicates | Automate Documentation | Track Competitors

Industry-leading Search Accuracy

We deliver the most accurate and effective medical device search algorithm on the market.

Based on a test set of n = 1000 actual FDA 510K summaries:

80%

Our algorithm correctly identifies actual Predicates used within the top 20 results 80% of the time

No other solution on the market supports free-form semantic search

92%

Conditioned on the actual Predicate appearing in the top 20, we achieve even greater accuracy - 92% of the time it's in the top 10, and 85% in the top 5

Using keyword extraction techniques and running the same experiment on FDA’s own search engine yields Predicate identification within top 50 results <5% of the time

Full Predicate lineage tracking and discovery of other products that use the same Predicates as your subject device.

No other search on the market has similar performance

Facilitate Product Development

Accelerate Regulatory Approval

Enhance Competitive Intelligence

AI-powered Semantic Search

Simply enter a device description to instantly retrieve a comprehensive list of relevant predicates. Uses the same technology that powers ChatGPT to deliver accurate results.

Predicate Lineage Tracking

View detailed information about a device, its Predicates, and any sibling devices that make use of the same Predicates. Stay informed on what else is out there on the market.

AI-Powered Predicate Analysis

Use generative AI to compare and analyze predicates side-by-side. Specify any custom criteria based on information from original 510k Summary files released by the FDA.

Chat with Your Predicate Candidates

Turn FDA predicate summaries into your own AI medical device expert. Have confidence in our AI's "context driven" answers with minimal risk for hallucinations.

Automate 510K Documentation

Never start from scratch when building your 510K Summary reports. Our AI is pre-trained on your chosen Predicate Summaries so you can leave the tedious parts of documentation to the AI and focus on the parts in which you are the expert.

Ready to Accelerate your FDA submission preparation?

If you have any questions, please email us at hello@approvo.ai