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Aerobiotix Announces FDA 510(k) Clearance of Medical Ultraviolet Air Filtration System


Aerobiotix Inc., a manufacturer of air treatment devices for hospitals and health care, has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Aerocure-MD medical air purification system. This system joins an expanding line of Aerobiotix technologies which utilize patented simultaneous mechanical and ultraviolet filtration to eliminate airborne contamination in clinical environments. Aerobiotix submitted independent data demonstrating effectiveness against viral and bacterial aerosols, as well as particulate contamination to support clearance.

The Aerocure-MD platform is unique in that it has FDA labeling to both destroy microorganisms in the air by exposure to ultraviolet radiation and also remove particles from the air via HEPA filtration. The system is designed for mobile, high-volume air decontamination applications in health care spaces such as acute care areas, contaminated storage and handling areas, and long-term health care facilities. Unlike other ultraviolet technologies, Aerobiotix uses a shielded internal ultraviolet system, preventing potentially hazardous exposure of personnel and material to ultraviolet rays.

“This clearance represents an important regulatory validation of our technology as we expand our footprint to cover all areas of health care. The growing challenge of airborne healthcare-acquired infections, including SARS-CoV-2, underscores the need for medical devices with rigorously investigated, peer-reviewed performance against airborne organisms in real-world clinical environments,” stated Dr. David Kirschman, MD, CEO of Aerobiotix, Inc.

Aerobiotix products, including the Illuvia nonturbulent air system for operating rooms, are used globally by leading medical centers and are supported by multiple published clinical studies.

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