«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



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