Drug news
FDA approves Inomax (Ikaria Inc) for compatibility with 3 additional devices
The Center for Devices and Radiological Health (CDRH) branch of the FDA has granted 510(k) clearance for compatibility of the Inomax drug-delivery systems, from Ikaria Inc., with three additional respiratory care devices. The Inomax DS and the Inomax DSIR have now been validated with nearly 60 makes of ventilators, anesthesia systems and other respiratory care devices. The Inomax DS and Inomax DSIR are proprietary drug-delivery systems that deliver Inomax (nitric oxide) for inhalation, the only drug approved by the FDA to treat Hypoxic Respiratory Failure (HRF) associated with Pulmonary Hypertension in term and near-term infants greater than 34 weeks gestational age. The Inomax drug-delivery systems are now compatible with the Fisher & Paykel Healthcare Bubble CPAP System and the Hamilton-C2 and Hamilton-G5 ventilators.
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