Nuvo Files 510(k) Submission for Expanded Use of Remote Pregnancy Monitor

Nuvo has filed a 510(k) submission with the FDA that seeks to add a new module to its already-cleared INVU remote pregnancy monitor.

The module, if cleared, would allow the monitoring platform to supervise maternal uterine activity that would alert healthcare providers to uterine contractions in pregnant women being monitored by the platform at home.

The platform has previously received 510(k) clearance for the remote monitoring and measurement of fetal and maternal heart rates.