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

GE HealthCare received FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, which will become available to U.S. customers later in the year.

The device, consisting of a wearable and wireless sensor, enables noninvasive measurement and display of fetal heart rate, maternal heart rate and uterine activity for pregnant patients at or beyond 34 weeks.

With the expanded indication granted by the FDA, Novii+, care teams can now use the monitoring solution for a more significant number of patients faced with high-risk pregnancies.  

Novii+ offers a personalized view of the mother’s and fetus’s statuses and can alert care teams for changes in heart rate and contraction pattern during labor, indicating whether an intervention is required.

The device is waterproof and can be left in place during a shower, providing continuous monitoring for the mother and fetus. 

Novii+ represents an enhanced version of the Novii Maternal and Fetal Monitoring Solution, incorporating an improved algorithm called Cross Check artifact reduction.

The algorithm is designed to cross-reference and validate data, reducing artifacts or unwanted interference.

THE LARGER TREND

In September 2023, GE HealthCare received a $44 million investment from the Bill and Melinda Gates Foundation to advance the development of AI-enabled ultrasound technology for maternal care.

Two months later, the Foundation granted Philips $60 million to expedite the integration of AI algorithms on the Lumify Handheld Ultrasound, aiding rural providers, including midwives, in identifying pregnancy abnormalities.