Obstetrics_gynecology
PeriCALM Patterns 3.0
PeriGen, Inc.
FDA
FDA-cleared AI medical device
Perinatal-monitoring software that analyzes intrapartum fetal heart-rate and uterine-activity tracings to flag pattern features for the clinical care team, intended as an adjunct to obstetrical surveillance.
FDA Submission Metadata
- Submission number
- K241009
- Decision date
- January 2025
- FDA panel
- Obstetrics and Gynecology
- Product code
- HGM
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