Healthcare AI Market and FDA Clearance Dataset
Get 583 verified records that connect FDA-cleared AI devices with device classes, companies, specialties, training programs, career roles, and published evidence citations.
FormatsCSV / JSON / XLSX
RefreshVersioned releases after source verification
Version1.0.0
VerifiedOctober 8, 2026
This release gives you connected records instead of a loose list of healthcare AI companies. Start with an FDA clearance, follow its device class and specialty, connect it to an applicant or company profile, then expand the research with sourced evidence, training, and career records.
The package is built for market research, data products, retrieval systems, and editorial research. It is deliberately nonclinical. No patient data, medical advice, outcome claims, or live market prices are included.
Designed For
- healthcare AI market maps
- FDA clearance research
- company and product intelligence
- nonclinical AI research systems
Coverage
Total records583 across eight connected tables
FDA clearances296 records across 26 device classes
Market records35 companies and 6 specialties
Research layer192 evidence citations across 8 topics
Career layer10 learning programs and 10 career roles
Field Dictionary
Schema Preview
| Field | Type | Description | Example |
|---|---|---|---|
k_number | string | FDA 510(k) clearance number | K243400 |
device_name | string | Cleared device name | AI-assisted imaging device |
product_code | string | FDA product code | QIH |
decision_date | date | FDA decision date | 2025-01-31 |
company_structure | string | Curated company ownership structure | public company |
source_url | url | Originating FDA, Europe PMC, or official source | https://www.accessdata.fda.gov/ |
last_verified | date | Most recent record verification date | 2026-10-08 |
Collection And Preparation
- Normalize FDA 510(k) records by clearance number, device class, product code, applicant, specialty, decision date, and source URL.
- Connect company profiles to factual market access fields while excluding share prices, market capitalization, and other time-sensitive quote data.
- Retain evidence citation facts and source links while excluding article abstracts from the commercial release.
- Preserve source URLs and verification dates so each record can be checked against its originating record.
Known Limits
- The release contains no patient records, protected health information, claims, diagnoses, treatment outcomes, or clinical predictions.
- FDA clearance does not establish clinical performance for a specific patient or use case.
- Evidence citations support research discovery. Buyers should read the linked papers before drawing conclusions.
- Company and security relationships can change after the stated verification date.
Useful Applications
- connect FDA clearances to device classes and applicants
- map healthcare AI companies and public market relationships
- compare specialties by clearance and device class coverage
- seed retrieval systems with sourced nonclinical records
- link evidence citations to healthcare AI subject groups
Change Log
- Published version 1.0.0 with 583 verified records, public samples, a complete codebook, and source links.