Royal Philips received Section 510 (k) approval for Avalon CL Fetal Monitoring solution.
Royal Philips announced that it received 510(k) clearance from the FDA to market its Avalon CL Fetal Monitoring solution (Avalon CL) using cableless technology. The solution provides consistent monitoring of the mother and child, without the burden of managing cables, allowing mothers more freedom of movement during labor. The product joins Philips' existing portfolio of mobility solutions designed for advanced monitoring and connected care across the health continuum, from healthy living and prevention, to diagnosis, treatment, recovery and home care.
By eliminating the discomfort of managing cables, Avalon CL allows women to move around and find the most comfortable position during labor, offering them more flexible birthing options, including showers and tubs. The solution continuously measures and transmits fetal heart rate and maternal pulse, uterine activity, and fetal or maternal ECG, allowing consistent monitoring while the mother is on the move.