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Thermavis was cited for marketing a Multi-Person Thermal Screening Camera as a device intended to prevent, mitigate, and screen for COVID-19 without FDA approval, clearance, or authorization. The company's website contained explicit claims that the thermal imaging product could help organizations prevent the spread of COVID-19 by screening for elevated body temperatures, thereby rendering the device both adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act. The product was being offered for sale in the United States without required premarket approval (PMA) or investigational device exemption (IDE) documentation.