Great regulatory services leveraging AI
Great regulatory services leveraging AI
By Yaz S.
The Fair Hearing score
4.0/ 5
New
4 reviews
Scores get a color once a company has 5 reviews.
CruxiAbout Cruxi
Cruxi is a vertical AI platform built specifically for medical device regulatory teams. It ingests FDA regulations, guidance, product codes, standards, MAUDE events, recalls, and prior 510(k) data to power agentic workflows for 510(k), De Novo, and eSTAR. Users can run rapid device classification, compare predicates, plan evidence, and generate fully cited, eSTAR-aligned content for each subsection of the submission. Cruxi offers both full-submission workflows and focused micro-services (e.g., classification, predicate analysis, specific section drafting), making it ideal for early-stage startups, in-house regulatory teams, and consultants who want to deliver high-quality submissions with less manual work and fewer surprises from FDA.
Cruxi (cruxi.ai) has 4 customer reviews on The Fair Hearing, with an average rating of 4.0 out of 5.
- Also known as
- cruxi.ai
- Website
- cruxi.ai
- Category
- Internet & Software
- Location
- Hartsdale, New York
- Listed on The Fair Hearing
- 2026