Masimo has announced that the firm’s Signal Extraction Technology (SET) pulse oximeters, rainbow SET Pulse CO-Oximeters, and neonatal sensors have been cleared by the FDA for use in screening newborns for critical congenital heart disease (CCHD).
This helps address a big, new need as a year ago, the U.S. Department of Health and Human Services added pulse oximetry screening of newborns for CCHD to the Recommended Uniform Screening Panel.
Some study results that led to the new clearance:
- Dr. Anne de-Wahl Granelli, et al., reported on the results of screening 39,821 newborn subjects at five maternity centers in Sweden. Investigators used the Masimo Radical™ with Masimo SET® technology, and found pulse oximetry screening of all well babies in maternity units is practically feasible with a minimum use of nursing time, and that it significantly improves detection of duct dependent heart disease before hospital discharge. The low false positive rate, the fact that other important pathology is unearthed by the screening, and the likely reduced need for preoperative neonatal intensive care suggest that such screening will be cost effective.
- Dr. Andrew Ewer, et al., studied 20,055 newborn subjects at six maternity centers in the UK. Investigators used the Radical-7® with Masimo rainbow® SET® technology and found pulse oximetry to be a safe, feasible test that adds value to existing screening. It identifies cases of critical congenital heart defects that go undetected with antenatal ultrasonography, and the early detection of other diseases is an additional advantage.
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