Penn Medicine-led, NIH-funded REACTIVE trial of 385 high-risk pregnancies shows the gain in adherence concentrated among women with public insurance, with no difference in maternal or neonatal outcomes
ON THIS PAGEKey findings·Investigator perspective·How the trial was conducted·What the results mean·About INVU™·About the trial·About Nuvo·Contacts·Further reading
Nuvo Intl Group Inc. (“Nuvo”), developer of the INVU™ remote fetal monitoring platform, today announced results of the REACTIVE trial, a randomized clinical trial conducted by researchers at the Perelman School of Medicine at the University of Pennsylvania and funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The trial found that women with high-risk pregnancies assigned to perform their prescribed non-stress tests remotely with INVU™ completed a greater share of those tests than women assigned to standard in-office testing, while making about half as many visits to the fetal testing unit.
Non-stress tests (NSTs) record the baby’s heart rate and uterine activity, and are prescribed in high-risk pregnancies to help clinicians judge fetal well-being and decide when closer evaluation or delivery may be needed. Women with high-risk pregnancies are often asked to attend the clinic for NSTs once or twice a week in the final weeks of pregnancy, a schedule that can be difficult to keep alongside work, childcare and transportation.
The trial’s pre-specified primary outcome was adherence: the share of prescribed NSTs each woman actually completed. Among the 385 women analyzed (193 remote, 192 in-office):
“Fetal monitoring is critical in high-risk pregnancies. It helps us recognize when a baby may be in distress and when closer evaluation or earlier delivery may be necessary,” said Nadav Schwartz, MD, Professor of Obstetrics and Gynecology and Director of Imaging in the Department of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania, principal investigator of the NIH award that funded the trial, a co-author of the study and a member of Nuvo’s Advisory Board. “Timely intervention can make a meaningful difference for both mother and baby. What’s especially encouraging about these findings is that women were able to complete more of this essential monitoring with substantially fewer routine testing visits, including women who often face the greatest barriers to care.”
REACTIVE (Remote Pregnancy Monitoring to Improve Access) enrolled women with singleton high-risk pregnancies at 32 to 36 weeks of gestation who had a clinical indication for antenatal NST surveillance, between May 2023 and February 2025. Participants were randomized 1:1 to standard in-office NSTs or to self-administered NSTs at home using INVU™. All NSTs in both groups were interpreted in real time by the same clinical team. In the remote group, in-person evaluation was recommended after a non-reactive or incomplete test or when blood pressure or symptoms raised concern. Of 400 women randomized, 385 were included in the analysis after withdrawals. Adherence was analyzed overall and by insurance status; secondary outcomes included testing characteristics, patient acceptability and maternal and neonatal outcomes.
For Nuvo, REACTIVE adds randomized, NIH-funded evidence from a University of Pennsylvania research team to INVU™’s clinical record. The trial shows that prescribed non-stress testing can move out of the clinic, with higher adherence and about half as many visits to the fetal testing unit, and no difference in test results or clinical decisions. That is the kind of evidence health systems look for before they change how care is delivered.
INVU™ by Nuvo is a prescription, wearable, non-invasive maternal-fetal monitoring platform that lets an expectant mother perform a prescribed non-stress test herself at home while her care team reviews the results remotely. Rather than relying on ultrasound, INVU™ reads the physiology of mother and baby directly:
INVU™ is cleared by the U.S. Food and Drug Administration under 510(k) premarket notification (K210025, 2021; K221046, 2022) as a maternal-fetal monitor that non-invasively measures and displays fetal heart rate, maternal heart rate and uterine activity, for use by healthcare professionals in healthcare facilities and by the patient at home on the order of a physician, in singleton pregnancies from 32 weeks of gestation, for antepartum fetal surveillance (non-stress testing). INVU™ does not prevent the onset of preterm labor or the occurrence of preterm birth. Its fetal heart rate, maternal heart rate and uterine-activity measurements have been compared with conventional cardiotocography in company-sponsored, peer-reviewed studies (Mhajna et al., 2020; Mhajna et al., 2022). INVU™ does not replace prenatal visits or emergency care. For complete indications, contraindications, warnings and precautions and instructions for use, visit www.nuvocares.com.
REACTIVE (ClinicalTrials.gov identifier NCT05847790) was sponsored and conducted by the University of Pennsylvania. The trial’s principal investigator is Samuel Parry, MD, Professor of Obstetrics and Gynecology; the principal investigator of the NIH award that funded it is Nadav Schwartz, MD. The study authors are Rebecca F. Hamm, Nadav Schwartz, Meaghan G. McCabe, Markolline Forkpa, Sunni L. Mumford, Naeemah Turner and Samuel Parry, all of the Perelman School of Medicine at the University of Pennsylvania. The trial was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under award number R01HD105446. The content of this release is solely the responsibility of Nuvo and does not necessarily represent the official views of the National Institutes of Health. Nuvo provided the INVU™ systems used in the trial. Dr. Schwartz is a member of Nuvo’s Advisory Board.
Trial information: https://clinicaltrials.gov/study/NCT05847790
Nuvo Intl Group Inc. is a women’s health technology company transforming pregnancy care by moving medically necessary fetal monitoring from the clinic to the mother’s home. Its FDA-cleared INVU™ platform combines a wearable multi-sensor band, a mobile app, a clinician dashboard and cloud-based signal processing to deliver remote, self-administered non-stress tests with real-time clinician review. Through years of regulated clinical use, INVU™ has recorded more than 25,000 remote monitoring sessions and more than 450,000 minutes of synchronized maternal and fetal physiological data — a longitudinal dataset that underpins Nuvo’s development of AI-driven, predictive pregnancy care. Nuvo works with health systems, clinicians and academic research centers in the United States and Israel to expand access to guideline-concordant prenatal surveillance, particularly for high-risk pregnancies and in communities with limited access to maternity care. Nuvo is headquartered in Aventura, Florida. To learn more, visit www.nuvocares.com.
Penn Medicine is one of the world’s leading academic medical centers, dedicated to the related missions of medical education, biomedical research, excellence in patient care, and community service.
The organization consists of the University of Pennsylvania Health System and Penn’s Raymond and Ruth Perelman School of Medicine, founded in 1765 as the nation’s first medical school.
The Perelman School of Medicine is consistently among the nation’s top recipients of funding from the National Institutes of Health, with more than $588 million awarded in the 2024 fiscal year. Home to a proud history of “firsts,” Penn Medicine teams have pioneered discoveries that have shaped modern medicine, including CAR T cell therapy for cancer and the Nobel Prize-winning mRNA technology used in COVID-19 vaccines.
The University of Pennsylvania Health System cares for patients in facilities and their homes stretching from the Susquehanna River in Pennsylvania to the New Jersey shore. UPHS facilities include the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, Chester County Hospital, Doylestown Health, Lancaster General Health, Princeton Health, and Pennsylvania Hospital—the nation’s first hospital, chartered in 1751. Additional facilities and enterprises include Penn Medicine at Home, GSPP Rehabilitation, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.
Penn Medicine is a $13.7 billion enterprise powered by more than 50,000 talented faculty and staff. For more information, visit www.pennmedicine.org.
This press release contains forward-looking statements, including statements about the potential benefits of remote fetal monitoring and of INVU™, the implications of the REACTIVE trial results, and Nuvo’s plans and expectations. Words such as “may,” “will,” “expect,” “believe,” “potential,” “could” and similar expressions identify forward-looking statements. These statements are based on Nuvo’s current beliefs and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including: whether the results of the REACTIVE trial will be reproduced in other settings and populations; the outcome of further clinical research; regulatory developments, including the scope of INVU™’s FDA clearance; adoption of remote monitoring by clinicians, health systems and payers; and Nuvo’s ability to fund and execute its plans. Nuvo is a privately held company. Except as required by law, Nuvo undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
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