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


GE HealthCare has received FDA clearance for its Novii+ maternal and fetal monitoring solution, allowing for noninvasive measurement and display of fetal and maternal heart rates and uterine activity. The device is wearable and wireless, providing continuous monitoring for high-risk pregnancies. It offers personalized status views and alerts care teams for changes during labor, while also incorporating an improved algorithm to reduce interference. The device is waterproof and can be left on during a shower. This clearance comes after GE HealthCare received a large investment from the Bill and Melinda Gates Foundation to advance AI-enabled ultrasound technology for maternal care. Additionally, the Foundation granted Philips a large sum to integrate AI algorithms into their handheld ultrasound technology.

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