FDA clears Ikaria's upgraded neonate drug delivery system

November 13, 2012 by MassDevice staff

Healthcare products maker Ikaria wins FDA 510(k) clearance for a software upgrade for its Inomax DSIR system.

Ikaria logo

Hampton, N.J.-based healthcare company Ikaria won FDA clearances for an upgraded software package and 3 non-invasive respiratory care devices for use with its Inomax DSIR drug delivery system.

The Inomax DS and DSIR deliver the company's proprietary Inomax vasodilator solution, which the company calls the only FDA-approved drug for treatment of infant hypoxic respiratory failure, associated with pulmonary hypertension.

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The new software package allows the Inomax DSIR to connect with a hospital's health information systems and to transmit data directly to electronic medical records.

The newly cleared respiratory care devices include the Fisher & Paykel Healthcare Infant Circuit Nasal Cannula and Optiflow Breathing Circuit and the A-Plus Medical Babi Plus Bubble CPAP, according to a press release.

A total of 60 ventilators, anesthesia systems and other respiratory care devices are now cleared for used with the Inomax DS and DSIR systems, the company noted.