Summary:
«Remote pregnancy monitoring company Nuvo Group announced today the FDA has granted supplemental 510(k) clearance to add a new uterine activity module to its INVU system.
INVU is a physician-prescribed, wearable pregnancy monitoring system that allows women to remotely collect fetal and maternal heart rates – and now uterine activity – while sharing data in real-time with their doctor.
The FDA indicates that INVU is used by pregnant people who are in their 32nd week of gestation or later with a singleton pregnancy. The clearance specifies that the device can be used to conduct non-stress testing, a common prenatal test used to check on a baby’s health.»
Article written by Mallory Hackett
10|06|2021
Source:
Mobi Health News
https://www.mobihealthnews.com/news/fda-greenlights-nuvo-groups-uterine-activity-module