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Talk to a SpecialistTalk to a SpecialistOpgal Optronic Industries Ltd. was warned for marketing thermal imaging devices called "Therm-App MD" and "Therm-App MD Pro" as unapproved medical devices intended to mitigate, prevent, and diagnose COVID-19, in violation of the Federal Food, Drug, and Cosmetic Act. The company's website, YouTube, Twitter, and Facebook pages contained claims that the products would "help prevent the spread of COVID-19," minimize coronavirus outbreaks, and provide "covid solutions" for fever screening at airports and other facilities. These marketing statements established that the products were intended for COVID-19 mitigation and diagnosis without FDA clearance or approval, making them both adulterated and misbranded. The FDA conducted its review in February 2021 during the height of COVID-19-related enforcement actions against unapproved diagnostic and preventive devices.