INFANT APNEA MONITOR STUDIES SHOULD LOOK AT DISTINCT APNEAS
This article was originally published in The Gray Sheet
INFANT APNEA MONITOR STUDIES SHOULD LOOK AT DISTINCT APNEAS rather than pooling data from different types of apnea, FDA's Anesthesiology and Respiratory Therapy Devices Panel suggested at a Sept. 2 meeting in Rockville, Maryland. Commenting on a revised 510(k) guidance document for apnea monitors, the panel said that each type of apnea -- central, obstructive, and mixed -- should be studied separately.
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