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Resources › Clinical Evidence › Part 2 of 5

Cleared by the FDA

Three 510(k) clearances, from fetal and maternal heart rate to contractions and remote nonstress tests.

2022
Invu by NuvoFDA 510(k) K221046 · cleared 6 May 2022

Special 510(k) for an updated version of the device.

US Food and Drug Administration
FDA record ↗510(k) summary ↗
2021
INVU by NuvoFDA 510(k) K210025 · cleared 28 May 2021

Added uterine activity and the nonstress-test indication, so NSTs can be done remotely.

US Food and Drug Administration
FDA record ↗510(k) summary ↗
2020
PregSense (now INVU)FDA 510(k) K191401 · cleared 27 Mar 2020

First clearance: fetal and maternal heart rate.

US Food and Drug Administration
FDA record ↗510(k) summary ↗

Keep exploring

More about INVU™ beyond the published research.

Press ReleasesCompany announcementsPartnerships, FDA clearances and studies, from 2020 to today.
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Email info@nuvocares.com ↗