The U.S. Food and Drug Administration has granted Xenex Disinfection Services a De Novo authorization for its LightStrike+ device.
drive up demandThe Xenex machines utilize high-intensity, broad-spectrum ultraviolet light to reduce potentially deadly pathogens, particularly on nonporous, high-touch surfaces in health care facilities. The regulatory decision authorizes the creation of a new medical device product classification, with the Xenex robots the first of their kind in the category.
Xenex has seen a surge in interest in its robots since the outbreak of COVID-19. A broad spectrum of venues, including restaurants, auto dealers and sports stadiums have utilized the devices. The De Novo authorization could drive up adoption of the technology and Xenex’s revenues too. It could also help bring some clarity to the industry stemming from a proliferation of companies utilizing UV technology during the height of the pandemic, according to Xenex CE Morris Miller.
“FDA authorization gives hospital decision-makers the confidence that Xenex’s claims for LightStrike+ are accurate and validated,” he said.
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