SAN ANTONIO – The U.S. Food and Drug Administration has granted Xenex Disinfection Services a De Novo authorization for its LightStrike+ instrument.
That choice is predicted to noticeably drive up demand for the San Antonio-based corporate’s germ-zapping robots.
The Xenex machines make the most of high-intensity, broad-spectrum ultraviolet mild to scale back doubtlessly fatal pathogens, specifically on nonporous, high-touch surfaces in well being care amenities. The regulatory choice authorizes the advent of a brand new scientific instrument product classification, with the Xenex robots the primary in their sort within the class.
Xenex has observed a surge in hobby in its robots because the outbreak of COVID-19. A extensive spectrum of venues, together with eating places, auto sellers and sports activities stadiums have applied the gadgets.
The De Novo authorization may power up adoption of the generation and Xenex’s revenues too. It may additionally assist convey some readability to the business stemming from a proliferation of businesses using UV generation right through the peak of the pandemic, consistent with Xenex CE Morris Miller.
“FDA authorization gives hospital decision-makers the confidence that Xenex’s claims for LightStrike+ are accurate and validated,” he mentioned.
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