Last updated: June 14, 2026
Back to directoryRemote pregnancy monitoring platform that uses a wearable sensor band and cloud-based processing to support clinician-ordered antepartum fetal surveillance from home or healthcare settings.
Programs that need a governed way to extend maternal-fetal surveillance outside the clinic while keeping ordering, review, interpretation, and escalation under clinician-controlled protocols.
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| Status | FDA-cleared Class II maternal-fetal monitor and home uterine activity monitor for ordered antepartum fetal surveillance workflows; verify current labeling and software version before deployment. |
|---|---|
| Review route | 510(k) K210025 and K221046. |
| Intended use | Non-invasively measures and displays fetal heart rate, maternal heart rate, and uterine activity for pregnant women at 32 weeks gestation or later with singleton pregnancy, for use by healthcare professionals or patients at home on physician order. |
| Verification note | Confirm current FDA database records, complete indications, contraindications, warnings, precautions, device version, care protocols, and whether any AI or predictive features are covered by the cleared intended use. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf22 |
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Nuvo INVU as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as FDA-cleared maternal-fetal monitoring software and hardware; match local use to the exact 510(k), gestational-age, singleton-pregnancy, prescription-use, antepartum-surveillance, home-or-facility, and non-preterm-prevention labeling. |
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| Privacy | Review patient app, clinician app, EMR API, monitoring-session data, sensor and shipping data, support recordings or transcripts, cloud processing, retention, subprocessors, BAA or provider agreement terms, and cross-border data handling before launch. |
| Evidence | Use FDA summaries, labeling, vendor materials, and a local pilot to test signal quality, patient setup, clinician review burden, missed sessions, false reassurance, escalation timing, and subgroup performance before relying on remote monitoring. |
| Workflow | Best governed as clinician-ordered remote antepartum surveillance with explicit patient instructions, monitoring windows, review queues, escalation paths, after-hours rules, downtime plans, and conversion-to-in-person-care criteria. |
Nuvo describes INVU as an AI-powered maternal-fetal remote monitoring platform that uses wearable sensors and cloud-based processing for fetal heart rate, maternal heart rate, and uterine activity monitoring. FDA 510(k) summaries K210025 and K221046 describe INVU by Nuvo as a Class II home uterine activity monitor for pregnant women at 32 weeks gestation or later with singleton pregnancy, ordered by a physician for antepartum fetal surveillance, and state that it does not prevent preterm labor or preterm birth.
Not for: Unsupervised fetal assessment, emergency triage, use before the labeled gestational-age scope, multiple gestations where unsupported, replacing in-person obstetric care, or patient self-use without physician order and care instructions.
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
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