Obstetrics_gynecology
Embryo Predict
Alife Health
FDA
FDA-cleared AI medical device
The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .
FDA Submission Metadata
- Submission number
- K250781
- Decision date
- May 2026
- FDA panel
- Obstetrics and Gynecology
- Product code
- PBH
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
Regulatory Approvals
FDA
US FDA 510k
K250781
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.