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

GE HealthCare acquired FDA 510(ok) clearance for its Novii+ maternal and fetal monitoring resolution, which is able to grow to be accessible to U.S. prospects later within the yr.

The machine, consisting of a wearable and wi-fi sensor, allows noninvasive measurement and show of fetal coronary heart fee, maternal coronary heart fee and uterine exercise for pregnant sufferers at or past 34 weeks.

With the expanded indication granted by the FDA, Novii+, care groups can now use the monitoring resolution for a extra vital variety of sufferers confronted with high-risk pregnancies.  

Novii+ affords a customized view of the mom’s and fetus’s statuses and might alert care groups for modifications in coronary heart fee and contraction sample throughout labor, indicating whether or not an intervention is required.

The machine is waterproof and could be left in place throughout a bathe, offering steady monitoring for the mom and fetus. 

Novii+ represents an enhanced model of the Novii Maternal and Fetal Monitoring Answer, incorporating an improved algorithm referred to as Cross Test artifact discount.

The algorithm is designed to cross-reference and validate information, decreasing artifacts or undesirable interference.


In September 2023, GE HealthCare acquired a $44 million funding from the Invoice and Melinda Gates Basis to advance the event of AI-enabled ultrasound expertise for maternal care.

Two months later, the Basis granted Philips $60 million to expedite the integration of AI algorithms on the Lumify Handheld Ultrasound, aiding rural suppliers, together with midwives, in figuring out being pregnant abnormalities.

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