The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) branch has granted 510(k) clearance to Ikaria's Inomax drug-delivery systems' compatibility with three additional respiratory care devices.
Following the FDA’s clearance, Inomax drug-delivery systems including Inomax DS and Inomax DSIR are compatible with the Fisher & Paykel Healthcare’s Bubble CPAP system and the Hamilton-C2 and Hamilton-G5 ventilators.
The Inomax DS and Inomax DSIR are proprietary drug-delivery systems which deliver Inomax (nitric oxide) for inhalation to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age.