FDA grants 510(k) clearance for Philips’ Avalon CL

7 January 2015 (Last Updated January 7th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Netherlands-based Royal Philips' Avalon CL Fetal Monitoring solution (Avalon CL).

Fetal

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Netherlands-based Royal Philips' Avalon CL Fetal Monitoring solution (Avalon CL).

The Avalon CL offers consistent monitoring of the mother and child, without the burden of managing cables, which enables mothers more freedom of movement during labour.

The product joins the company's existing portfolio of mobility solutions designed for advanced monitoring and connected care across the health continuum.

Philips Healthcare patient care and monitoring solutions CEO Mike Mancuso said: "Conventional fetal monitoring solutions present limitations for physicians and patients alike.

"This latest cableless technology enhances clinician confidence and allows women more flexibility and freedom of movement during labour, which can be very beneficial to the woman and child."

"Avalon CL is said to continuously measure and transmit fetal heart rate and maternal pulse, uterine activity, and fetal or maternal electrocardiogram (ECG)."

Allowing consistent monitoring while the mother is on the move, Avalon CL is said to continuously measure and transmit fetal heart rate and maternal pulse, uterine activity, and fetal or maternal electrocardiogram (ECG).

According to multiple research studies, mothers who have freedom of movement during labour may have significantly shorter labour lengths, as well as reduced need for pain relief or labour induction drugs.

The Avalon CL Fetal Monitoring solution features patented Smart Pulse technology that is developed to automatically detect heart rate coincidence between the maternal pulse and the fetal heart rates, even for twins and triplets.

The solution transmits information about fetal and maternal vital signs to a monitor through the base station. From there, patient information will be transferred to the Philips IntelliSpace Perinatal information management system.

It tracks medical information across the obstetrical care continuum, from the first antepartum visit to delivery, postpartum, newborn record, discharge and postpartum follow-up visits.


Image: Philips receives FDA approval for its latest Avalon CL Fetal Monitoring solution. Photo: courtesy of PRNewswire / Royal Philips.