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

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GE Healthcare has received FDA 510(k) clearance for its Novii+ maternal and child monitoring solution, which will be available to U.S. customers later this year.

The device consists of a wearable wireless sensor that enables non-invasive measurement and display of fetal heart rate, maternal heart rate, and uterine activity in pregnant patients from 34 weeks onwards.

The FDA-approved expanded indication for Novii+ allows medical teams to use the monitoring solution for more patients facing high-risk pregnancies.

Novii+ can provide a personalized view of the mother and fetus’ condition, alerting the care team to changes in heart rate and contraction patterns during labor and indicating whether intervention is needed.

The device is waterproof and can be left in place while showering, providing continuous monitoring of the mother and fetus.

Novii+ represents an enhanced version of the Novii maternal and child monitoring solution that incorporates an improved algorithm called Cross Check Artifact Reduction.

The algorithm is designed to cross-reference and validate data to reduce artifacts and unnecessary interference.

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In September 2023, GE Healthcare received a $44 million investment from the Bill & Melinda Gates Foundation. AI-enabled ultrasound technology for maternal care.

Two months later, the foundation awarded Phillips a $60 million grant. Lumify integrates AI algorithms into handheld ultrasounds to help local healthcare providers, including midwives, identify abnormalities in pregnancy.

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