Aerobiotix announced today that it received FDA 510(k) clearance for its Aerocure-MD medical air purification system.
Miamisburg, Ohio-based Aerobiotix’s Aerocure-MD platform received FDA labeling to destroy microorganisms in the air by exposure to ultraviolet radiation and also remove particles in from the air via HEPA filtration, according to a news release.
Aerocure-MD is designed for mobile, high-volume air decontamination applications in healthcare spaces including acute care areas, contaminated storage and handling areas and long-term healthcare facilities. The system uses a shielded internal ultraviolet system to prevent potentially hazardous exposure of personnel and material to ultraviolet rays.
The company said it submitted independent data demonstrating effectiveness against viral and bacterial aerosols, along with particulate contamination to support clearance.
“This clearance represents an important regulatory validation of our technology as we expand our footprint to cover all areas of healthcare,” Aerobiotix CEO Dr. David Kirschman said in the release. “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.”