Noxilizer wins 510(k) clearance for NO2 sterilization of medical device

by Fink Densford for Medical Design and Outsourcing

Novel sterilization firm Noxilizer on Wednesday touted the FDA 510(k) clearance of a device which is terminally sterilized using the company’s nitrogen dioxide sterilization process.

The Baltimore, Md.-based company touts NO2 sterilization as “unique” as it sterilizes at low temperatures, between 10-30°C, and functions without a vacuum or humidity. Noxilizer says those aspects of the NO2 based sterilization make it ideal for temperature sensitive medical devices and biotech drugs.

“Receiving a FDA clearance marks a pivotal milestone for Noxilizer. This clearance confirms that nitrogen dioxide sterilization is another option for companies – especially for those products, like prefilled syringes, drug-delivery systems and medical devices — that face challenges with ethylene oxide, gamma radiation or other conventional sterilization methods,” CEO Lawrence Bruder said in prepared remarks.

The FDA clearance establishes a pathway to 510(k) approvals for other devices sterilized by NO2, the company said.

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