GE HealthCare scores 510(k) clearance for maternal and fetal monitoring platform

The US FDA has granted 510(k) clearance to GE Healthcare’s Novii+ maternal and foetal monitoring system. The wearable, wireless sensor measures and displays maternal and foetal heart rates and uterine activity in patients at or beyond 34 weeks. The sensor can also alert care teams to changes in heart rate and contraction patterns during labour. Novii+ will now be available to a greater number of patients with high-risk pregnancies.