FDA Radiology AI Devices

The Sonicaid Team3 is a fetal monitoring system designed for non-invasive and invasive monitoring of fetal and maternal physiological parameters during pregnancy. It helps clinicians assess fetal well-being through ultrasound, fetal heart rate monitoring, and includes the Dawes-Redman CTG analysis software to evaluate cardiotocographs, aiding in the identification of abnormal or reassuring fetal heart patterns.

PeriCALM Patterns 3.0 is an AI-based software tool designed to assist clinicians in monitoring fetal well-being during pregnancy and labor. It analyzes fetal heart rate and uterine contraction signals, automatically identifying patterns such as accelerations, decelerations, baseline heart rate, and contractions. This information supports clinical decision-making for pregnant patients at or beyond 32 weeks of gestation by providing annotated summaries of the fetal monitor recordings.