The devices, which include Masimo’s SET pulse oximeters and Rainbow SET pulse co-oximeters, were previously cleared for measuring oxygen saturation levels and pulse rate in newborns, but the new labeling provides specific indication for use during physical CCHD screening, according to a press release.
In conjunction with the FDA win Masimo also launched a new program, the Help Ensure Access to the Right Technology initiative, to provide access to CCHD screening to under-served areas.
"Before SET pulse oximetry, CCHD screening was impractical, if not impossible with pulse oximetry," Masimo founder and CEO Joe Kiani said in prepared remarks. "Masimo SET delivered the groundbreaking results of high sensitivity and specificity that became the basis for this new standard of care."
The medical device maker should have some extra time to make progress on the new initiative. Kiani told investors recently that Masimo isn’t weighing any more big moves on the mergers & acquisitions front, looking instead to either increase dividend payments to shareholders or execute a share buyback.