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Devices Monitoring FDA

 News Release - January 7, 2015

Philips receives FDA 510(k) clearance for its latest Avalon CL Fetal Monitoring solution

Advanced cableless solution detects fetal heart rate and maternal pulse allowing beneficial freedom of movement during labor

ANDOVER, Mass., Jan. 7, 2015 -- (Healthcare Sales & Marketing Network) -- Royal Philips (NYSE: PHG AEX: PHIA) today announced that it received 510(k) clearance from the U.S.A. Food and Drug Administration (FDA) to market its Avalon CL Fetal Monitoring solution (Avalon CL). 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.

"Conventional fetal monitoring solutions present limitations for physicians and patients alike," said Mike Mancuso, CEO of Philips Healthcare's Patient Care and Monitoring Solutions. "This latest cableless technology enhances clinician confidence and allows women more flexibility and freedom of movement during labor, which can be very beneficial to the woman and child."

Allowing movement during labor

Multiple research studies have shown that mothers who have freedom of movement during labor may have significantly shorter labor lengths1,2, as well as reduced need for pain relief or labor induction drugs3. Research also reveals less frequent abnormal heart rate patterns for women in an upright position, as well as less pain and backache4 during labor. 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.

Enhancing diagnosis accuracy

Misinterpreting the maternal heart rates as fetal during the second stage of labor is a significant concern for clinicians. Avalon CL includes patented Smart Pulse technology designed to automatically detect heart rate coincidence between the maternal pulse and the fetal heart rates, even for twins and triplets. This helps reduce the possibility of mistaking one heartbeat for another, supporting timelier intervention.

As part of the Philips Fetal and Maternal Monitors portfolio, Avalon CL expands Philips commitment to working with customers for creating innovative solutions that connect care across the health system. Avalon CL transmits fetal and maternal vital signs information to a monitor via the base station. From there, patient information can be transferred seamlessly to the Philips IntelliSpace Perinatal information management system, which tracks medical information across the obstetrical care continuum – from the first antepartum visit to delivery, postpartum, newborn record, discharge and postpartum follow-up visits.

For more information on Philips advanced technology solutions for mother and child care, visit and follow @PhilipsHealth.

For further information, please contact: Kathy O'Reilly
Tel: +1 978-659-2638
Mobile: +1 978-221-8919
Twitter: @kathyoreilly

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people's lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2013 sales of EUR 23.3 billion and employs approximately 115,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at

1 A. Lawrence , L. Lewis, GJ Hofmeyr, T. Dowswell, C. Styles, "Maternal positions and mobility during first stage labour." Cochrane Database of Systematic Reviews (2009): Issue 2. Art. No. CD003934, doi:10.1002/14651858, CD003934. pub2.

2 Gupta JK , Nikodem VC., "Woman's position during second stage." Cochrane Library.

3 Flynn et al., "Ambulating in labour," Br Med J. (1978) Aug 26, 2 (6137):591-3.

4 World Health Organization, "Care in Normal Birth," (1996): 60 pages.

Source: Royal Philips

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