Ikaria, a medical device manufacturer based in Hampton, New Jersey, received 510(k) clearance from the United States Food and Drug Administration for a new upgrade. The upgrade is designed for the company’s Inomax DSIR system. The clearances from the FDA include a new software package for the system and three new respiratory care devices for non-invasive use.
The company’s Inomax DSIR and DS are used as part of a drug delivery system for the company’s Innomax vasodilator solution. According to Ikaria, the Innomax vasodilator solution is one of the only drugs approved by the FDA for use in infants with hypoxic respiratory failure.
The new software package for the Inomax DSIR and DS is designed to enhance connectivity between the device and information systems at a hospital or other healthcare facility. In addition, the new software upgrade allows the device to write information to a patient’s electronic medical records.
The three new non-invasive respiratory devices include the Optiflow Breathing Circuit, the Fisher & Paykel Healthcare Infant Circuit Nasal Cannula and the A-Plus Medical Babi Plus Bubble CPAP. According to a press release by the company, a total of 60 anesthesia systems, ventilators and other respiratory devices have received clearance from the FDA for use with the Inomax DSIR and DS systems.
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