Obstetrics_gynecology
CHLOE BLAST
Fairtility Ltd.
FDA
FDA-cleared AI medical device
Machine-learning clinical decision-support software that analyzes time-lapse images of embryos to provide objective, consistent assessment as an aid to embryologists during in-vitro fertilization.
FDA Submission Metadata
- Submission number
- K243851
- Decision date
- August 2025
- FDA panel
- Obstetrics and Gynecology
- Product code
- PBH
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA