FDA-cleared AI obstetrics and gynecology devices
The FDA's AI-enabled device list has 5 devices whose lead review panel is Obstetrics and Gynecology, 0.3% of all 1,614 listed devices. They come from 5 companies. The first decision was on March 16, 2006 and the most recent on May 15, 2026.
5AI devices
5Companies
2006First decision
2026-05-15Latest decision
Trend: devices per year
2006201920252026
Top companies
Most common product codes
All 5 devices, newest first
- Embryo PredictAlife Health · Obstetrics and Gynecology
- CHLOE BLASTFairtility Ltd. · Obstetrics and Gynecology
- PeriCALM Patterns 3.0PeriGen, Inc. · Obstetrics and Gynecology
- KIDScore D3Vitrolife A/S · Obstetrics and Gynecology
- LUMA CERVICAL IMAGING SYSTEMSPECTRA SCIENCE · Obstetrics and Gynecology
Frequently asked questions
How many FDA-cleared AI obstetrics and gynecology devices are there?
As of the FDA list updated through June 29, 2026, 5 AI-enabled devices have Obstetrics and Gynecology as their lead review panel (0.3% of the list).
Which companies have the most AI obstetrics and gynecology devices?
Alife Health (1), Fairtility Ltd. (1), PeriGen, Inc. (1) have the most AI-enabled obstetrics and gynecology devices on the FDA list.
Which year had the most AI obstetrics and gynecology authorizations?
2025 had the most, with 2 devices.
Which FDA pathways are used for AI obstetrics and gynecology devices?
510(k): 4; PMA: 1.
What was the most recent AI obstetrics and gynecology device on the list?
Embryo Predict from Alife Health (K250781), with a decision dated May 15, 2026.