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Mallinckrodt gets FDA approval for INOmax DSIR Plus MRI device

Biopharmaceutical firm Mallinckrodt has received approval from the US Food and Drug Administration (FDA) for its INOmax DSIR Plus MRI device to deliver Inomax (nitric oxide) for inhalation during MRI procedures.

The system was developed to deliver Inomax for inhalation therapy gas into the patient-breathing circuit to provide a constant concentration of nitric oxide (NO) to the patient.

According to the company, it is indicated for use only with magnetic resonance conditional ventilators validated to be compatible, as identified in the device labeling.

The approval was based on the determination of substantial equivalence to the INOmax DSIR. It has the same intended therapeutic effect and patient population as the previously cleared INOmax DSIR predicate device.

All versions of INOmax DSIR family of delivery systems use component technology to deliver INOmax to the patient. The components include delivery system unit, INOblender, stand/cart and INOmax cylinders.

The new version features cart hardware, INOmax delivery cable and tubing, gas sampling tubing, advanced software and labeling, specifically designed for use in the MRI suite.

Mallinckrodt Pharmaceuticals senior vice-president and chief scientific officer Dr Steven Romano said: "INOmax DSIR Plus MRI was developed with the goal of enhancing patient care and making it easier for physicians to perform an MRI while maintaining their patients on INOMAX therapy."