Use of In-Home Non-Stress Monitoring Device for Fetal Monitoring: A Nonsignificant Risk (NSR) Device Study

This is a prospective, single-visit, non-randomized, comparative study designed to evaluate the PregnaOne System, an investigational Class II medical device intended for in-home fetal monitoring. The system includes the Pregnabit Pro device and associated software that collect and transmit data on fetal heart rate, fetal movement, maternal pulse rate, and uterine muscle activity for remote review by healthcare professionals. The goal of this study is to assess the safety, usability, and signal performance of the PregnaOne System compared to the INVU system, an FDA-cleared home fetal monitoring device. The study will be conducted under a non-significant risk (NSR) designation. Approximately 70 pregnant women in their third trimester will be enrolled at three U.S. medical centers. Each participant will attend one in-clinic visit simulating an at-home environment. The study visit includes: Training session - participants are instructed on how to use the PregnaOne System. First monitoring session - a 30-minute fetal monitoring period using both the PregnaOne System and the INVU system simultaneously. Second monitoring session - a 30-minute self-conducted monitoring session using only the PregnaOne System without staff assistance. During each session, participants remain in a seated or reclined position and record fetal movements. Study staff will be available to assist and ensure participant safety. No known risks are associated with fetal heart rate monitoring, though mild discomfort from device straps may occur. Participants receive compensation for their time and travel. Study data will support the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA).