Mallinckrodt Announces FDA Clearance of the INOmax® EVOLVE™ DS Delivery System and Approval of the INOmax® (nitric oxide) Mini-Cylinder [Yahoo! Finance]
Medtronic plc. Ordinary Shares (MDT)
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Source: Yahoo! Finance
– The INOmax EVOLVE DS also earned recognition from the Human Factors and Ergonomics Society (HFES) for this year's innovative design – DUBLIN Dec. 7, 2023 /PRNewswire/ -- Mallinckrodt plc , a global specialty pharmaceutical company, today announced that the INOmax ® EVOLVE ™ DS delivery system has been cleared by the U.S. Food and Drug Administration (FDA) for the delivery of INOmax ® (nitric oxide) gas, for inhalation. The INOmax EVOLVE DS delivers INOmax into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with the ventilators and respiratory care devices for which INOmax EVOLVE DS has been validated. Please see Applications and Device Warnings below
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