GeNO has announced it has received FDA clearance for its inhaled nitric oxide delivery system, according to a news release (pdf).
The system, the GeNOsyl MV-1000, includes four components: the primary delivery system, a backup system, the NO gas analyzer, and the NO2 gas analyzer. It is designed to inject a constant flow of nitric oxide gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient and provide continuous integrated monitoring of inspired oxygen, NO and nitrogen dioxide concentrations, and a comprehensive alarm system, according to the company.
The GeNOsyl MV-1000 is the first apparatus developed by GeNO that received FDA clearance.
"This marketing clearance is a major milestone for our unique NO delivery technology," said GeNO Founder and President Dr. David Fine, in the release. "The MV-1000 is GeNO's first delivery apparatus to receive marketing clearance from FDA. We welcome this first approval from FDA as we move all of our platforms forward through clinical development."
GeNO is headquartered in Waltham, Mass.
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