GE HealthCare has successfully obtained FDA 510(k) clearance for its advanced Novii+ maternal and fetal monitoring solution, with plans to make it available to U.S. customers later this year. The Novii+ system, featuring a wearable and wireless sensor, allows for noninvasive measurement and real-time display of fetal heart rate, maternal heart rate, and uterine activity in pregnant patients at or beyond 34 weeks.
This expanded clearance by the FDA broadens the application of Novii+, enabling care teams to utilize the monitoring solution for a larger population of patients facing high-risk pregnancies. The device offers a personalized view of both the mother’s and fetus’s statuses, providing timely alerts to care teams for changes in heart rate and contraction patterns during labor, facilitating prompt interventions when necessary.
Designed to withstand water exposure, Novii+ is waterproof and can be worn during a shower, ensuring continuous monitoring for both the mother and fetus. An upgraded version of the Novii Maternal and Fetal Monitoring Solution, Novii+ incorporates the Cross Check artifact reduction algorithm, enhancing data accuracy by cross-referencing and validating information to minimize artifacts and unwanted interference.
The Larger Trend:
In a broader context, this achievement follows GE HealthCare’s significant strides in maternal care technology. In September 2023, the company received a substantial $44 million investment from the Bill and Melinda Gates Foundation to advance the development of AI-enabled ultrasound technology for maternal care. Building on this momentum, two months later, the Foundation granted Philips $60 million to expedite the integration of AI algorithms on the Lumify Handheld Ultrasound. This initiative aims to support rural providers, including midwives, in promptly identifying pregnancy abnormalities, emphasizing the ongoing commitment to advancing maternal healthcare through cutting-edge technology.
