{"id":58000,"date":"2023-09-05T13:01:58","date_gmt":"2023-09-05T11:01:58","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fda-grants-xenex-authorization-for-lightstrike-uv-robot-via-de-novo-first-only-microbial-reduction-robot-for-healthcare-facilities\/"},"modified":"2023-09-05T13:01:58","modified_gmt":"2023-09-05T11:01:58","slug":"fda-grants-xenex-authorization-for-lightstrike-uv-robot-via-de-novo-first-only-microbial-reduction-robot-for-healthcare-facilities","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fda-grants-xenex-authorization-for-lightstrike-uv-robot-via-de-novo-first-only-microbial-reduction-robot-for-healthcare-facilities\/","title":{"rendered":"FDA Grants Xenex Authorization for LightStrike+ UV Robot via De Novo \u2013 First & Only Microbial Reduction Robot for Healthcare Facilities"},"content":{"rendered":"
\n

SAN ANTONIO–(BUSINESS WIRE)–#COVID19<\/a>–The U.S. Food and Drug Administration (\u201cFDA\u201d) has granted Xenex Disinfection Services, Inc.<\/a> (\u201cXenex\u201d) De Novo authorization for the company\u2019s LightStrikeTM<\/sup>+ device, a high-intensity, broad-spectrum<\/a> ultraviolet (UV) light robot. The authorization creates a new medical device product classification under which the LightStrike+ robot is the first and only product of its type, setting the precedent for FDA regulation of UV robots intended for use in reducing pathogens on non-porous, high-touch surfaces in the healthcare environment.<\/p>\n

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\nLightStrike+ devices<\/a> are intended to perform microbial reduction on non-critical medical device surfaces free from visual soiling in the healthcare environment following manual cleaning and disinfection practices. They are authorized for use in healthcare facilities, including unoccupied operating rooms, hospital rooms, and other clinical settings where non-critical medical devices may be present.<\/p>\n

\nMore than 1,200 healthcare facilities<\/a> worldwide have run LightStrike robots over 37 million cycles. With as low as a 2-minute run-time for microbial reduction, the new LightStrike+ device is built upon accumulated knowledge from more than a decade of best practices implemented at healthcare facilities, 45 peer-reviewed studies<\/a> demonstrating safe and effective use, 193 patents, and industry leading technical and epidemiological expertise. Many of the world\u2019s leading hospitals, including HonorHealth, Mayo Clinic, MD Anderson Cancer Center, Ochsner Health System, Stanford Health Care and Texas Health Resources use LightStrike robots as part of their comprehensive disinfection strategy.<\/p>\n

\nDangerous pathogens remain on surfaces in healthcare facilities, even after thorough manual cleaning efforts. The LightStrike+ robot uses a xenon lamp to create high-intensity pulsed UV light that reduces the number of those pathogens on surfaces and helps to break the chain of transmission from one patient or healthcare worker to the next. Xenex\u2019s FDA authorization is supported by rigorous testing performed on over 10,000 samples of vegetative bacteria and Clostridiodes difficile (C.diff)<\/i> spores.<\/p>\n

\n\u201cWe have been working with our hospital partners for over a decade to support them in their mission to improve patient safety and public health. As an infectious diseases epidemiologist, I am highly concerned about antibiotic resistance in the hospital environment. I hope that FDA authorization will allow hospitals to more easily use this tool in their fight against pathogens,\u201d said Dr. Mark \u201cTuck\u201d Stibich<\/a>, founder and Chief Scientific Officer of Xenex.<\/p>\n

\n\u201cWe understand that it can be challenging for hospitals to evaluate UV technologies, especially given the unverified and often exaggerated claims made by some manufacturers. FDA authorization gives hospital decision-makers the confidence that Xenex\u2019s claims for LightStrike+ are accurate and validated,\u201d said Xenex Chief Executive Officer Morris Miller.<\/p>\n

\nManufactured in San Antonio, Texas, LightStrike+ robots are now available.<\/p>\n

\nAbout Xenex Disinfection Services<\/span><\/p>\n

\nXenex is a world leader in innovative UV technology-based strategies and solutions. Xenex’s mission is to enable its partners to save lives and reduce suffering by destroying the deadly microorganisms that can cause infections. Xenex is backed by well-known investors that include EW Healthcare Partners, Piper Sandler, Malin Corporation, Battery Ventures, Targeted Technology Fund II, Tectonic Ventures and RK Ventures. For more information, visit xenex.com.<\/a><\/p>\n

Contacts<\/b> <\/p>\n

\nMelinda Hart
\n
Xenex
\n
210 240 4669
\n
Melinda.hart@xenex.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

SAN ANTONIO–(BUSINESS WIRE)–#COVID19–The U.S. Food and Drug Administration (\u201cFDA\u201d) has granted Xenex Disinfection Services, Inc. (\u201cXenex\u201d) De Novo authorization for the company\u2019s LightStrikeTM+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot. The authorization creates a new medical device product classification under which the LightStrike+ robot is the first and only product of its type, setting … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-58000","6":"format-standard","7":"category-industry"},"yoast_head":"\nFDA Grants Xenex Authorization for LightStrike+ UV Robot via De Novo \u2013 First & Only Microbial Reduction Robot for Healthcare Facilities - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/fda-grants-xenex-authorization-for-lightstrike-uv-robot-via-de-novo-first-only-microbial-reduction-robot-for-healthcare-facilities\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Grants Xenex Authorization for LightStrike+ UV Robot via De Novo \u2013 First & Only Microbial Reduction Robot for Healthcare Facilities - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"SAN ANTONIO–(BUSINESS WIRE)–#COVID19–The U.S. Food and Drug Administration (\u201cFDA\u201d) has granted Xenex Disinfection Services, Inc. (\u201cXenex\u201d) De Novo authorization for the company\u2019s LightStrikeTM+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot. The authorization creates a new medical device product classification under which the LightStrike+ robot is the first and only product of its type, setting ... 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