Aventura, Florida, USA, November 5, 2026
Nuvo Intl Group Inc. has announced positive findings from the REACTIVE (Remote Pregnancy Monitoring to Improve Access) randomized clinical trial, which evaluated the use of its INVU™ remote maternal-fetal monitoring platform for non-stress testing (NST) in high-risk pregnancies. The study, conducted by researchers at the Perelman School of Medicine at the University of Pennsylvania and supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the U.S. National Institutes of Health (NIH), found that women assigned to remote, self-administered testing completed a greater proportion of their prescribed fetal monitoring sessions than women receiving standard in-office testing. The results, announced by Nuvo on November 5, 2026, also showed that participants using the remote platform made approximately half as many visits to the fetal testing unit. The findings suggest that appropriately supervised home-based monitoring could help reduce practical barriers to recommended antenatal surveillance while maintaining clinical oversight.
REACTIVE Trial Reports Higher Testing Adherence
The trial included 385 women with high-risk singleton pregnancies, analyzed after participants were randomized to either remote NSTs using INVU™ or conventional in-office testing. Participants were between 32 and 36 weeks of gestation and had a clinical indication for antenatal non-stress testing. The study’s pre-specified primary outcome was adherence to prescribed testing. Women in the remote-monitoring group completed a median of 92.0% of their prescribed NSTs, compared with 85.5% in the in-office group. In addition, 48.7% of women in the remote group completed every prescribed test, compared with 33.9% of those assigned to standard in-office monitoring. The adherence improvement was particularly evident among participants with public insurance: median adherence was 73.0% with remote testing versus 60.0% with in-office testing. Among privately insured participants, median adherence was 100% in both groups. These findings highlight the potential value of remote monitoring for patients who may face transportation, work, childcare or other access challenges when attending repeated clinic appointments. A notable operational finding was the reduction in visits to the fetal testing unit. Women assigned to remote monitoring averaged 3.3 visits, compared with 6.3 visits among those receiving in-office testing. In the remote group, a median of 76.9% of remote NST attempts were completed entirely outside the clinical facility. The remote tests did take longer on average, with monitoring time of 35.1 minutes compared with 27.5 minutes for in-office tests. Patient acceptability scores were also higher in the remote group, at 32.0 compared with 30.5 on a scale ranging from 8 to 40. Together, these results indicate that home-based testing may improve convenience and adherence, although it requires appropriate technology, patient instruction and clinical review.
INVU™ Platform Supports Clinician-Led Home Testing
INVU™ is a prescription-based, wearable, non-invasive maternal-fetal monitoring platform designed to allow pregnant women to perform prescribed NST sessions at home. Its sensor band uses passive biopotential electrodes and acoustic sensors to capture maternal and fetal heart signals, alongside motion data. The information is transmitted to Nuvo’s cloud-based platform, where signal-processing technology generates fetal heart rate, maternal heart rate and uterine-activity tracings for review by the healthcare team. Through the INVU™ mobile application, patients can complete and upload scheduled monitoring sessions, while clinicians use the INVU™ Pro dashboard to review the results and determine appropriate next steps. Clinical interpretation and care decisions remain with healthcare professionals, rather than being delegated to the monitoring device.
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Importantly, the trial reported no differences between the groups in non-reactive test rates, additional biophysical profile assessments, delivery recommendations resulting from testing, or measured maternal and neonatal outcomes. These included outcomes such as cesarean delivery, preterm birth and neonatal intensive care unit admission. The study was not evidence that remote monitoring eliminates the need for in-person assessment. Participants were advised to undergo in-person evaluation when a test was non-reactive or incomplete, or when symptoms or blood pressure raised concerns.
Clinical Significance and Regulatory Context
The REACTIVE trial adds randomized clinical evidence to the evaluation of remote fetal surveillance. INVU™ has received U.S. FDA 510(k) clearance for specified maternal-fetal monitoring uses, including non-stress testing in singleton pregnancies from 32 weeks of gestation, when ordered by a physician. The platform is intended for use by healthcare professionals in healthcare facilities and by patients at home under physician direction. It does not replace routine prenatal visits, emergency care or clinical assessment when concerns arise. Nuvo also notes that its investigational predictive models for conditions such as preeclampsia and preterm birth are not part of the device’s FDA clearance. The REACTIVE study was sponsored and conducted by the University of Pennsylvania and funded through an NIH award. Nuvo supplied the INVU™ systems used in the research. Further evaluation in additional healthcare settings and patient populations will help determine how broadly the findings can be applied. Overall, the results support the potential of clinician-supervised remote non-stress testing to improve adherence and reduce routine facility visits for some high-risk pregnancies, while keeping medical decisions within the care team.
Source: Nuvo press release
