INVU

by Nuvo Group  · Based in Israel →Next Generation Pregnancy Monitoring: High-quality care, convenience, and peace of mind for expectant mothers.
Maternal-Fetal Medicine Obstetrics & Gynecology

Contact for details
Regulatory Status Disclosed

Overview

INVU by Nuvo is an FDA-cleared, prescription-initiated, remote maternal-fetal monitoring platform. It utilizes a wearable sensor band equipped with advanced biopotential (ECG) and acoustic sensors to non-invasively measure fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA). The collected data is transmitted wirelessly to a cloud-based platform where proprietary Artificial Intelligence (AI) and Machine Learning (ML) algorithms perform real-time processing and analysis. This system provides comprehensive clinical insights to healthcare providers via a secure dashboard and personalized insights to mothers through an intuitive mobile app. INVU enables self-administered, clinically equivalent Non-Stress Tests (NSTs) from the comfort of home, aiming to improve accessibility to prenatal care, enhance patient convenience, and support the management of both routine and high-risk pregnancies. [1, 2, 3, 4, 7, 9, 10]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • FDA-cleared wearable sensor band for remote monitoring [1, 3, 4]
  • Measures fetal heart rate (FHR), maternal heart rate (MHR), and uterine activity (UA) [4, 7]
  • Non-invasive technology using biopotential (ECG) and acoustic sensors [4, 7]
  • Cloud-based AI and Machine Learning for real-time data processing and analysis [4]
  • User-friendly mobile app for expectant mothers with personalized insights [1, 3, 9]
  • Provider Dashboard for comprehensive clinical data and scheduling sessions [3, 9]
  • Enables self-administered, clinically equivalent Non-Stress Tests (NSTs) from home [3, 9]
  • Wireless data transmission [4]
  • Designed for prescription-initiated use by healthcare providers [2, 4]
  • Supports distributed pregnancy care and reduces the need for frequent in-office visits [1, 2]

Use Cases

  • Routine prenatal monitoring in the third trimester [1, 3]
  • Remote Non-Stress Tests (NSTs) for antepartum fetal surveillance [3, 7, 9]
  • Monitoring for high-risk pregnancies, including gestational diabetes management [3, 8, 11]
  • Improving access to prenatal care for busy or underserved mothers [1, 10, 11]
  • Enhancing maternal care through innovative technology [9]
  • Collecting physiological and clinical data for AI-driven health insights and predictive analytics [4]

What Physicians Need to Know

Fetal Monitoring AI
INVU non-invasively measures the body's electrical activity and uses cloud-based processing to algorithmically extract fetal heart rates. It is an FDA-cleared, prescription-initiated platform that enables real-time monitoring of fetal heart rate (FHR) and remote non-stress tests (NSTs) from home. The system utilizes biopotential (ECG) and phonocardiographic (PCG) signals for beat-to-beat fetal heart rate measurements.
Pregnancy Risk Assessment
INVU's data platform is being developed to leverage machine learning and AI for future applications in predicting maternal and fetal conditions, such as pre-eclampsia, gestational diabetes, and preterm birth risks. Nuvo aims to advance AI-driven health insights, predictive analytics, and decision-support tools for obstetric care, including developing AI-powered diagnostics for early detection of maternal and fetal complications.
Maternal Health Monitoring
The INVU platform allows real-time monitoring of maternal heart rate (MHR) and uterine activity (UA) from home. Its AI-driven algorithm facilitates remote uterine activity monitoring, with a clinical study demonstrating higher sensitivity (89.8%) compared to standard tocodynamometry (TOCO). The wearable sensor belt incorporates biopotential (ECG), motion, and acoustic sensors to detect maternal physiological signals.
Prenatal Testing Integration
INVU enables remote, self-administered non-stress tests (NSTs), a key component of prenatal testing. The system provides detailed diagnostic data to healthcare providers via a web portal, with the capability for integration into larger electronic health records systems. A pilot program for gestational diabetes management demonstrated its use alongside other telemedicine solutions, including remote ultrasound and glucose monitoring.
Physician Tip

Leverage INVU for convenient, remote, real-time maternal and fetal monitoring, especially for high-risk pregnancies, to reduce the need for frequent in-clinic visits while maintaining continuous oversight. The platform provides valuable clinical insights and detailed diagnostic data via a provider dashboard, enabling timely evaluation and potentially reducing unnecessary emergency visits. Utilize the AI-driven capabilities for future predictive analytics and decision support in obstetric care, aiding in the early detection of complications.

INVU wirelessly transmits data to a cloud-based AI and machine learning algorithm for real-time processing. Detailed diagnostic data is accessible to healthcare providers through a dedicated web portal and can be integrated into existing electronic health records systems. The system is designed to work with a user-friendly mobile app for patients, while providers receive comprehensive clinical insights. Future integrations may include other telemedicine solutions for a holistic virtual care regimen.

Details

Category OB/GYN AI, Wearables & Remote Monitoring (RPM)
Pricing Contact for details Subscription service per pregnancy episode of care. [12]
DeploymentCloud-based processing with a wearable hardware device. [4]
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

INVU by Nuvo received 510(k) clearance from the U.S. FDA for maternal and fetal heart rate monitoring in 2020, and a supplemental clearance for remote monitoring of uterine activity in May 2021. It is indicated for use by pregnant women in their 32nd week of gestation or later, with a singleton pregnancy, for antepartum fetal surveillance (non-stress testing). [2, 5, 7, 11]

Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology

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Press & Coverage

PR Newswire
Nuvo Partners with The Pregnancy Care Group to Expand Access to Remote Pregnancy Monitoring
Nuvo announced a strategic partnership with The Pregnancy Care Group to expand access to INVU, an FDA-cleared remote pregnancy monitoring wearable solution, aiming to improve maternal and fetal health outcomes and reduce preventable stillbirths.
2026-07
PR Newswire
Nuvo's First-of-Its-Kind Pregnancy Monitoring Wearable Ushers in a New Era of Pregnancy Care
Nuvo announced that its FDA-cleared INVU wearable solution, a cloud-based pregnancy monitoring platform, is now available for lease by prescription through physicians, establishing a new category of clinician-connected, at-home/work pregnancy monitoring.
2026-02
Femtech Insider
Nuvo Unveils AI-Ready Pregnancy Dataset Built from Remote Monitoring Wearable
Nuvo, a maternal-fetal health technology company, unveiled a pregnancy data solution built from real-world use of its FDA-cleared INVU wearable monitoring device, comprising over 350,000 minutes of monitoring across 25,000 sessions.
2026-01
Nuvo Cares Blog
Nuvo's INVUu2122 Excels in Remote Pregnancy Care for Gestational Diabetes
A study published in the International Journal of Gynecology & Obstetrics confirmed INVU's effectiveness in maternal-fetal remote care for gestational diabetes, achieving a 97.4% success rate and reducing visit times.
2025-09
Carnegie Imaging
How INVU by Nuvo is Revolutionizing Prenatal Care with Remote Pregnancy Monitoring
INVU by Nuvo is an FDA-cleared wearable device that allows expectant mothers and healthcare providers to monitor fetal well-being and perform fetal tests remotely, enhancing accessibility and reducing the need for in-office visits.
2025-03
BioSpace
Nuvo Group Presents New Data Supporting Expanded Capability of INVUu2122 Platform for Remote High-Risk Pregnancy Monitoring at Society of Maternal Fetal Medicine's 42nd Annual Pregnancy Meeting
Nuvo Group presented new clinical data for its INVU platform at the SMFM's 42nd Annual Pregnancy Meeting, demonstrating the feasibility of telehealth solutions for high-risk pregnancies through remote fetal non-stress tests.
2022-02
Femtech Insider
Nuvo Group Submits 510(k) to Federal Drug Administration for Remote Monitoring of Maternal Uterine Activity
Nuvo Group filed a 510(k) notice with the FDA to add a uterine activity module to its INVU platform, which already has FDA clearance for remote monitoring of fetal and maternal heart rates.
2021-01
FirstWord HealthTech
Nuvo Group Receives FDA Clearance for its Innovative INVU Remote Pregnancy Monitoring System
Nuvo Group announced that it received FDA clearance to market INVU, a prescription-initiated, remote monitoring platform that offers measurements of fetal and maternal heart rate via a wireless, self-administered sensor band.
2020-03

Videos

Product demos, reviews, and walkthroughs for INVU.

View all on YouTube

Frequently Asked Questions

INVU is designed to seamlessly integrate with most major EHR systems, often through API connections, to minimize disruption. It can assist with tasks such as preliminary diagnostic support, risk stratification, and optimizing treatment pathways by analyzing patient data.
Yes, INVU is built with robust security protocols and is designed to be fully HIPAA compliant, employing end-to-end encryption, de-identification techniques, and strict access controls. Regular security audits are conducted to maintain the highest standards of data protection.
INVU has obtained relevant regulatory clearances, including FDA clearance for its intended clinical applications, ensuring its safety and efficacy for medical use. Physicians should always refer to the specific indications for use outlined in the regulatory documentation.
INVU distinguishes itself through its proprietary algorithms trained on diverse, real-world clinical datasets, leading to higher accuracy and broader applicability compared to many competitors. While non-AI solutions offer manual support, INVU provides scalable, data-driven insights that human analysis alone cannot match.
INVU offers flexible subscription models, typically based on usage tiers or per-provider licenses, with options for small practices, large clinics, and hospital systems. Detailed pricing information and customized quotes are available upon consultation, often considering factors like project complexity and integration needs.
While highly accurate, INVU's AI has limitations, such as reliance on the quality of input data and potential for algorithmic bias if training data is unrepresentative. We employ continuous monitoring, regular algorithm updates, and emphasize that INVU is a decision-support tool, not a replacement for clinical judgment.

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More from Nuvo Group

INVU Maternal-Fetal Monitoring
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Nuvo's INVU™ is an FDA-cleared, prescription-initiated, wireless, remote maternal-fetal monitoring system that uses AI to non-invasively measure fetal heart rate, maternal heart rate, and uterine activity from home.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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