Mallinckrodt Wins FDA Clearance for INOmax DSIR Plus MRI Device
Specialty biopharmaceutical company Mallinckrodt has received FDA clearance for its INOmax DSIR Plus MRI device for the delivery of nitric oxide for inhalation during MRI procedures.
The system provides a constant concentration of nitric oxide to the patient, and is indicated for use only with magnetic resonance-conditional ventilators validated to be compatible.
Clearance is based on the determination of substantial equivalence to the INOmax DSIR. The new device includes hardware modifications to the cart, as well as a software update with an MRI set-up wizard and modified labeling.
The company plans to commercialize the device this month. —Michael Cipriano