Ikaria gets FDA OK for new software on infant drug delivery device

11/14/2012 | MassDevice.com (Boston)

The FDA has given Ikaria 510(k) clearance to update software on its Inomax DSIR device designed to deliver the firm's Inomax vasodilator agent, an FDA-approved treatment for infant hypoxic respiratory failure tied to pulmonary hypertension. The firm also gained FDA clearance for three devices used with the Inomax DSIR for noninvasive respiratory care.

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