GE Health Care received 510(k) clearance from the FDA for its Novii+ maternal and fetal monitoring solution, which will be available to U.S. customers later this year.
The device, which consists of a wearable, wireless sensor, allows non-invasive measurement and visualization of fetal heart rate, maternal heart rate and uterine activity in pregnant patients 34 weeks or older.
With the FDA-granted expanded indication of Novii+, care teams can now use the monitoring solution for a more significant number of patients facing high-risk pregnancies.
Novii+ offers a personalized view of the condition of the mother and fetus and can alert care teams to changes in heart rate and contraction pattern during labor, indicating whether intervention is required.
The device is waterproof and can be left in place during the shower, providing continuous monitoring of 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 BIGGEST TREND
In September 2023, GE HealthCare received a $44 million investment from the Bill & Melinda Gates Foundation to advance the development of AI-based ultrasound technology for maternal care.
Two months later, the Foundation awarded Philips $60 million to accelerate the Integration of AI algorithms into Lumify portable ultrasound, helping rural providers, including midwives, identify pregnancy abnormalities.