clearance

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

GE HealthCare received FDA 510(k) clearance for its Novii+ maternal and fetal monitoring solution, which will become available to U.S. customers later in the year. The device, consisting of a wearable and wireless sensor, enables noninvasive measurement and display of fetal heart rate, maternal heart rate and uterine activity for pregnant patients at or beyond …

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

Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance

Surgical robotics and mixed reality company Zeta Surgical announced it secured FDA special 510(k) clearance for advanced functionalities and expanded compatibility of its cranial navigation system for neurosurgery. The mixed-reality navigation system offers surgeons real-time “GPS-like” guidance with millimeter precision. With a computer vision engine ensuring continuous accuracy despite patient movement, the company says the system …

Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance Read More »

Shopping Cart