Masimo has declared that its rainbow SET Pulse CO-Oximeters, Masimo Signal Extraction Technology (SET) pulse oximeters, and neonatal sensors with labeling for screening newborns has received U.S. FDA 510(k) clearance for critical congenital heart disease (CCHD).
Earlier clearance allowed Masimo SET pulse oximeters and sensors to determine pulse rate and oxygen saturation while under motion and low perfusion conditions in newborns. Now, for the first time the FDA has cleared specific labeling, representing the adoption of pulse oximeters coupled with a physical exam, for screening newborns for CCHD.
Besides the FDA clearance, Masimo also declared the HEART Program (Help Ensure Access to the Right Technology) for CCHD screening, through which certain hospitals can have access to a free Masimo SET pulse oximeter.
CCHD is responsible for causing 3% of infant deaths. The U.S. Department of Health and Human Services (HHS) states that such heart defects impact around 7 to 9 of every 1,000 live births, 25% of which can be diagnosed and treated by measuring blood oxygen saturation. FDA clearance follows the California’s recent mandate CCHD pulse oximetry screening, after HHS's September 2011 initiative to complement pulse oximetry CCHD screening for newborns involved in Recommended Uniform Screening Panel.
With intent to support the new CCHD screening labeling, the following studies were submitted by Masimo to the FDA:
- Dr. Anne de-Wahl Granelli, et al., report on the outcome of screening 39,821 newborn subjects at five maternity centers in Sweden.
- Dr. Andrew Ewer, et al., report on 20,055 newborn subjects at six maternity centers in the UK.
Masimo SET pulse oximetry is being offered as both standalone and integrated products in more than 100 multiparameter monitors from over 50 brands. Masimo’s HEART Program (Help Ensure Access to the Right Technology) for CCHD screening will promote Masimo SET technology for CCHD screening to hospitals.
The Masimo pulse oximeters with 510(k) clearance include the Rad-5, Rad-5v and Rad-8 Pulse Oximeters with Masimo SET and the Radical-7, Rad-57 and Rad-87 Pulse CO-Oximeters with Masimo rainbow SET.
Source: http://www.masimo.com/