FDA Clears New Module for Nuvo Group’s Remote Pregnancy Monitoring System

The FDA has granted additional 510(k) clearance for Nuvo Group’s Invu system, a platform for remotely monitoring pregnancy.

The agency has cleared a new module for the system that allows it to be used for the remote monitoring of uterine activity. The system, which can now be used to remotely recognize uterine contractions in women, uses only external sensors, avoiding the need for in-hospital or in-clinic procedures.

The Invu system previously received FDA clearance for the remote monitoring of fetal and maternal heart rates.