First OTC, app-connected COVID-19 test authorized by FDA

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First OTC, app-connected COVID-19 test authorized by FDA

Alongside step-by-step instructions, the Ellume COVID-19 Home Test’s accompanying app automatically reports users’ results to the relevant public health authorities.

The U.S. FDA announced today an Emergency Use Authorization for the first over-the-counter COVID-19 diagnostic test for home use.

Developed by Australian digital diagnostics company Ellume Health, the single-use kit is accompanied by a Bluetooth-connected app that guides users through the testing process and automatically reports its results for disease monitoring.

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