# Freenome, LLC: PMA approval for SimpleScreen™ CRC

**Score:** 55/100

| Field | Value |
|---|---|
| Sponsor | Freenome, LLC |
| Product | SimpleScreen™ CRC |
| Generic / ingredient | System, colorectal neoplasia, DNA methylation and hemoglobin detection |
| Approval | PMA original approval (new class III device) |
| Application | P250029 |
| Decided | 2026-07-24 |
| Panel / class | Medical Genetics |
| Sponsor location | Brisbane, CA |

## Why this score
- A new product launch.

Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250029). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.