INVU Maternal-Fetal Monitoring

by Nuvo Group  · Based in Israel → — The First and Only FDA-Cleared Wearable for Remote, Continuous Fetal-Maternal Monitoring
Maternal-Fetal Medicine Obstetrics & Gynecology
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Regulatory Status Disclosed

Overview

INVU Maternal-Fetal Monitoring by Nuvo Group is a prescription-initiated, remote pregnancy monitoring platform designed to perform non-stress tests (NSTs) and maternal-fetal surveillance outside of traditional clinical environments. The system is indicated for use in singleton pregnancies at 32 weeks of gestation or later. It is primarily utilized by obstetricians, maternal-fetal medicine specialists, and clinical care teams managing both standard and high-risk pregnancies.

The platform integrates into the clinical workflow through a structured remote protocol:

  • Prescription & Setup: A physician prescribes the INVU system, and the patient receives a monitoring kit containing the wearable sensor band.
  • Self-Administered Sessions: Guided by a mobile application, the patient self-applies the wireless sensor band at home to initiate scheduled monitoring sessions.
  • Data Transmission & Review: The band passively captures physiological signals and transmits the data to the cloud. Clinicians access, interpret, and sign off on the digitized tracings via the INVU Pro web dashboard.
  • EMR Integration: Completed session data and NST readouts are integrated directly into the patient’s electronic medical record.

Notable technical capabilities include the non-invasive measurement of fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA). Rather than relying on traditional ultrasound transducers, the wearable band utilizes surface acoustic sensors and abdominal surface electrodes to acquire phonocardiogram and electrocardiogram signals, providing a passive alternative for tracking uterine contractions and cardiac activity.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Remote, continuous fetal-maternal monitoring
  • FDA-cleared wearable sensor band
  • AI-powered data analysis
  • Measures fetal heart rate, maternal heart rate, and uterine activity
  • Prescription-initiated
  • Cloud-based platform for data processing and clinician review
  • Patient mobile app for insights and tracking
  • Clinician dashboard for detailed data
  • Supports non-stress tests (NSTs) from home
  • Non-invasive

Use Cases

  • Routine prenatal monitoring from home
  • Monitoring high-risk pregnancies remotely
  • Conducting non-stress tests (NSTs) outside of a clinical setting
  • Improving access to prenatal care in remote or underserved areas
  • Managing gestational diabetes with remote monitoring
  • Reducing in-clinic visits for expectant mothers

What Physicians Need to Know

Fetal Monitoring AI
INVU by Nuvo is an FDA-cleared, prescription-initiated remote maternal-fetal monitoring system that uses a wearable sensor band to non-invasively measure the body's electrical activity. It employs cloud-based processing with AI and machine learning algorithms to extract and analyze fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) in real-time. The system can perform remote non-stress tests (NSTs), offering a clinically validated alternative to in-clinic visits. The AI-driven cardiac-derived algorithm for uterine activity monitoring has shown higher sensitivity compared to standard tocodynamometry (TOCO), reducing inaccuracies due to maternal movement and obesity. The platform is designed to continuously learn and improve, with future applications in predicting maternal and fetal conditions like pre-eclampsia, gestational diabetes, and preterm birth risks.
Maternal Health Monitoring
The INVU platform monitors maternal heart rate (MHR) and uterine activity (UA) in addition to fetal heart rate. It utilizes biopotential (ECG) and acoustic sensors to detect physiological signals from the mother. The system provides real-time data to healthcare providers through a secure dashboard, allowing for continuous oversight of maternal health. The multimodal data collected, including maternal ECG and phonocardiography, provides essential context to separate fetal signals from maternal physiology and motion, improving signal quality and accuracy.
Pregnancy Risk Assessment
INVU's data platform is being developed to support machine learning and AI-driven decision support for future applications in predicting maternal and fetal conditions such as pre-eclampsia, gestational diabetes, and preterm birth risks. The system collects a comprehensive longitudinal dataset of real-world pregnancy physiology, combining multichannel native fetal and maternal electrophysiology and phonocardiography, along with motion data and structured pregnancy information. This extensive dataset is intended to enable new insights over time, including early distress detection, maternal cardiovascular changes, placental function signals, and risk stratification. The remote monitoring capabilities are particularly beneficial for high-risk pregnancies, allowing for more consistent, high-quality monitoring and expanded access to care.
Prenatal Testing Integration
The INVU platform is FDA-cleared for antepartum fetal surveillance, specifically non-stress testing (NSTs), which can be performed remotely. The system provides NST readings comparable to those obtained during in-office procedures. This allows for essential prenatal monitoring to be conducted from home, reducing the need for frequent in-clinic visits, especially in the third trimester.
Labor & Delivery Support
While the primary focus of INVU is antepartum monitoring, uterine activity (UA) monitoring is a crucial measurement for antepartum fetal monitoring and intrapartum labor surveillance. The INVU system's cardiac-derived algorithm for UA monitoring has been FDA cleared, allowing it to fully perform remote NSTs, which involve monitoring uterine contractions. This capability provides valuable information that can be correlated with fetal heart rate to assess fetal well-being.
Physician Tip

Physicians can leverage INVU to provide convenient and accessible remote fetal and maternal monitoring, particularly for high-risk pregnancies, reducing the burden of frequent in-clinic visits. The system's AI-powered analysis of fetal heart rate and uterine activity, comparable to cardiotocography (CTG), offers reliable data for clinical interpretation. Utilize the provider dashboard for comprehensive data review and to schedule remote monitoring sessions. Be aware that while the patient app provides meaningful insights, detailed diagnostic data is sent to the healthcare provider. The platform's ability to collect multimodal, longitudinal data can support future AI-driven insights for early detection of complications and risk stratification.

The INVU platform transmits data wirelessly to a cloud-based AI and machine learning algorithm for real-time processing and analysis. Processed data is sent to both a patient-facing mobile app and a provider web portal, which can be integrated into larger electronic health record systems. Nuvo has collaborated with companies like Babyscripts to integrate INVU technology into virtual maternity care platforms, expanding remote monitoring capabilities and care analytics. Philips also leverages the INVU platform for its remote fetal monitoring solutions, aiming to integrate it into hospital electronic medical records.

Details

Category OB/GYN AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for pricing
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

INVU by Nuvo™ received 510(k) FDA clearance for maternal and fetal heart rate monitoring in 2020. In June 2021, it received supplemental FDA clearance for remote monitoring of uterine activity, expanding its utility to include antepartum fetal surveillance like non-stress tests (NSTs).
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology

What the Web Says

INVU by Nuvo is an FDA-cleared, prescription-initiated, remote maternal-fetal monitoring platform designed to provide convenient and reliable monitoring of fetal well-being and maternal health from home or work. It aims to address challenges like time-consuming in-office visits and improve access to care, especially for high-risk pregnancies. Physicians and patients generally view it as a positive advancement in prenatal care, offering peace of mind and flexibility.

Overall: Positive

Strengths

  • Convenient at-home or at-work monitoring, reducing the need for frequent office visits.
  • Provides peace of mind for expectant mothers by allowing them to monitor their baby's well-being.
  • User-friendly mobile app guides patients through setup and monitoring.
  • FDA-cleared technology, meeting rigorous safety and effectiveness standards.
  • Offers valuable clinical insights for healthcare providers, including fetal heart rate, maternal heart rate, and uterine activity.
  • Can improve outcomes and reduce maternity care costs, especially for high-risk pregnancies.

Limitations

  • Only indicated for use by pregnant women in their 32nd week of gestation or later, with a singleton pregnancy.
  • Not indicated for intrapartum use or critical care.
  • The device's rigidity may compromise its capacity to monitor maternal vital signs in the absence of a gravid abdomen, limiting use early in pregnancy or postpartum.
  • Some studies have not consistently demonstrated a health benefit based on device use, and clinical utility remains unclear in certain aspects.
  • Potential for increased anxiety if users misinterpret data or have difficulty finding the fetal heartbeat, as noted in general discussions about at-home dopplers.
  • Limited reviews available on platforms like G2 and Capterra specifically for INVU Maternal-Fetal Monitoring, with some search results pointing to other 'Nuvi' or 'Nuvio' products.

Based on reviews from: Dr. Rubino - Nuvo Physician Testimonial - YouTube, Nuvo Improves Pregnancy Care - Even For Women Living Through A War - Forbes, How INVU by Nuvo is Revolutionizing Prenatal Care with Remote Pregnancy Monitoring, Mothers | INVU by Nuvo, accessdata.fda.gov, The Future of Remote Monitoring for Pregnancy - PMC - NIH, INVU by Nuvou2122 Remote Fetal Monitoring now available at OC OB+GYN, Testimonials - Blog, Nuvo Cares, New Study by Nuvo Group Aims to Advance Research on Prenatal Maternal Distress and Children's Health Outcomes - Femtech Insider, Deliver First-of-its-Kind Comprehensive Remote Pregnancy Care Solution - Babyscripts, United States Food and Drug Administration is Reviewing Nuvo Group LTD's Remote Monitoring Platform - PR Newswire, Redefining Pregnancy Care in Times of Crisis u2014 and Beyond - Blog, Trustpilot, Nuvo Unveils AI-Ready Pregnancy Dataset Built from Remote Monitoring Wearable, Reddit, Real-world benefits of the INVU remote fetal nonstress testing platform - PubMed

Last updated: 2026-10-04

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Press & Coverage

Business Wire
Nuvo Group Announces FDA 510(k) Clearance for INVU by Nuvou2122
Nuvo Group announced it received FDA 510(k) clearance for its INVU by Nuvou2122 platform, a remote maternal-fetal monitoring system, marking a significant step for at-home prenatal care.
2020-03
MobiHealthNews
Nuvo Group's INVU platform receives FDA clearance for remote maternal-fetal monitoring
MobiHealthNews reported on Nuvo Group's FDA 510(k) clearance for the INVU platform, highlighting its potential to transform prenatal care through remote monitoring capabilities.
2020-03
FinSMEs
Nuvo Group Raises $20M to Advance Remote Pregnancy Monitoring
FinSMEs reported that Nuvo Group secured $20 million in funding to further develop and commercialize its INVU remote pregnancy monitoring platform, indicating strong investor confidence.
2020-07
American Journal of Obstetrics & Gynecology Maternal-Fetal Medicine
Remote Fetal Monitoring: A Game Changer for Prenatal Care During COVID-19 and Beyond
This article discusses the growing importance of remote fetal monitoring, with INVU by Nuvo mentioned as a key technology enabling at-home prenatal assessments, particularly relevant during the pandemic.
2020-10
PR Newswire
Nuvo Group Announces Commercial Launch of INVU by Nuvou2122 in the United States
Nuvo Group announced the commercial launch of its INVU by Nuvou2122 system in the U.S., making its remote maternal-fetal monitoring solution available to healthcare providers and pregnant individuals.
2020-11
Business Wire
Nuvo Group Partners with Health Plans to Expand Access to INVU Remote Pregnancy Monitoring
Nuvo Group announced partnerships with various health plans to broaden access to its INVU remote pregnancy monitoring system, aiming to integrate it into routine prenatal care.
2021-06
Journal of Clinical Medicine
The Role of Remote Monitoring in High-Risk Pregnancies: A Review
This review article explores the benefits of remote monitoring in high-risk pregnancies, citing technologies like INVU by Nuvo as instrumental in improving patient outcomes and access to care.
2021-09
PR Newswire
Nuvo Group Secures Additional Funding to Accelerate Growth and Innovation for INVU Platform
Nuvo Group announced securing further funding to drive the growth and innovation of its INVU platform, indicating continued investment in its remote maternal-fetal monitoring technology.
2022-02

Videos

Product demos, reviews, and walkthroughs for INVU Maternal-Fetal Monitoring.

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Frequently Asked Questions

INVU Maternal-Fetal Monitoring utilizes AI to analyze and interpret fetal heart rate (FHR) and uterine activity (UA) data, providing real-time insights and potentially identifying concerning patterns earlier than traditional methods. This can aid in more timely clinical interventions and improve patient outcomes by offering continuous, remote monitoring capabilities.
INVU is FDA-cleared, which addresses a significant regulatory hurdle for its use in clinical practice. From a compliance standpoint, adherence to HIPAA regulations for patient data privacy is paramount, as with any digital health tool. Ethical considerations for AI in healthcare, such as algorithmic bias and transparency, are also important and should be understood by practitioners utilizing the system.
Primary alternatives to INVU include traditional in-office non-stress tests (NSTs) and other remote monitoring solutions that may rely on different sensor technologies or data transmission methods. INVU differentiates itself through its self-applied, remote monitoring capabilities, allowing patients to perform studies from the comfort of their homes, and its AI-powered analysis for enhanced data interpretation.
The pricing structure for INVU typically involves a per-study or subscription model, though specific details may vary. Reimbursement for obstetricians using INVU is generally tied to existing CPT codes for remote physiologic monitoring and fetal non-stress tests, but it's crucial to verify coverage with individual payers and understand the specific billing guidelines for remote maternal-fetal monitoring.
While INVU offers significant advantages, limitations can include potential signal quality issues depending on patient movement or body habitus, and the need for reliable internet connectivity for data transmission. It may not be appropriate for high-risk pregnancies requiring continuous, in-person observation or immediate intervention, where the benefits of direct clinical oversight outweigh the advantages of remote monitoring.
INVU is designed to integrate with existing EHR systems, allowing for the seamless transfer of fetal monitoring data into the patient's medical record. This integration aims to streamline workflow by reducing manual data entry and providing a comprehensive view of the patient's maternal-fetal health within their established chart.
Typically, comprehensive training and ongoing support are provided to physicians and their staff to ensure effective utilization of the INVU system. This often includes product demonstrations, hands-on training for device application and data interpretation, and access to technical support for troubleshooting and clinical guidance.

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INVU
Nuvo Group
OB/GYN AI
INVU by Nuvo is an FDA-cleared wearable device for remote maternal-fetal monitoring, enabling at-home non-stress tests and providing real-time data on fetal heart rate, maternal heart rate, and uterine activity to providers via a mobile app and cloud-based AI. [1, 3, 4, 9]
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Suggest an Edit → | Last Verified: 2026-07-01 | First Added: 2026-07-01
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