Thursday, June 30, 2022
Invictus Sterilization LLC., a Hickory, NC based provider of Hospital-Grade UV-C based surface and air sterilization products, announced today that the U.S. Food and Drug Administration (FDA) cleared its Aura Storm as a Class II ultraviolet medical air purifier. The Aura Storm air purifier is a free standing, air purification device utilizing ultraviolet light and a multi-stage filtration system for the inactivation of bacteria and viruses in hospitals and other medical related facilities. With this clearance, the Aura Storm will now be offered as a medical device to hospitals, nursing homes, hospice facilities, and other medical and dental offices to mitigate risks associated with airborne threats such as the coronavirus, monkeypox, and HAI (Hospital Acquired Infections). The FDA clearance was contingent on an extensive amount of testing conducted at accredited independent third-party testing facilities.
"Invictus is excited to have successfully completed the 510(k)-clearance process," said Invictus CEO Erik McMillan. "Hospital Acquired Infections (HAIs) are responsible for billions of dollars in unnecessary medical expenditures each year. Our Invictus Aura Storm helps to mitigate that by providing the most economical unit on the market in terms of protected area and pathogen coverage per dollar spent. Invictus will continue this journey by having its other units complete the FDA 510(k) certification process in the upcoming months."
Dr. Tulika Narain of SV Professional Center in Patchogue, NY has been operating multiple Aura Storm units throughout the medical clinic. "We understand the airborne transmission of bacteria and viruses and are deeply invested in the safety of our patients, staff, and their families. We were excited to deploy a high-level of air purification and protection to our facility and utilized the Aura Storm air purifier to provide protection in our waiting area, common areas, and staff areas. The FDA-clearance delivers peace of mind regarding the effectiveness of these air purifiers."
