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U.S. Health & Human Services Makes Critical Congenital Heart Defect Screening Using Motion-Tolerant Pulse Oximetry a Nationwide Newborn Screening Standard
Date:9/23/2011

IRVINE, Calif., Sept. 23, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that the U.S. Department of Health & Human Services (HHS) has added Critical Congenital Heart Defects (CCHD) screening using motion-tolerant pulse oximetry as a national newborn screening standard.  In addition, the largest UK study of pulse oximetry screening for CHD detection, published online in the Lancet (appearing in the November 2011 print edition), demonstrates that when Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry was used to screen newborns before hospital discharge, it enabled clinicians to increase CHD detection and provided a cost-effective method for universal screening with high sensitivity.(1)

An International Problem—Undetected / Undiagnosed CHD in Newborns

Among the approximately 4.2 million babies born in the U.S. annually,(2) CHD is the most prevalent form of birth defect and is the #1 cause of infant death.(3)  HHS estimates that approximately 7-9 babies per 1,000 live births have some form of CHD.(3)  Yet, up to 30% of infant deaths from CHD occurred before diagnosis(4)—leading many to question the effectiveness of current newborn screening methods. Current methods of CHD detection rely largely on newborn physical examination but fail to identify approximately 50% of CHD cases(5)—leaving many vulnerable newborns undiagnosed at hospital discharge.

The Strategy for a Nationwide Solution—"Motion-Tolerant Pulse Oximetry"

In a letter dated September 21, 2011, HHS Secretary Kathleen Sebelius outlined the decision to adopt expert panel recommendations for universal CCHD screening
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SOURCE Masimo Corporation
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