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Becton, Dickinson, and Company, or BD, announced on August 27, that the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for the BD Veritor At-Home COVID-19 Test. This test is the first at-home COVID-19 rapid antigen test to use a smartphone to interpret and provide a display of testing results. The test does not require a prescription, a laboratory, or a long wait for results1.

Proposed in late February, the FDA’s emergency authorization comes just in time as delta variant cases are on the rise.

The digital test will not need a prescription, but will only be initially available to employers, schools, and public health organizations to help support and increase routine screening programs1.

In collaboration with Scanwell Health, the rapid antigen test operates similar to a home pregnancy test. After swishing a nasal swab in a tube of reagent, the individual will drop some of the solution of a testing strip, which will activate colored lines after about 15 minutes. Using the smartphone’s camera, the individual will scan the test to read and interpret the results of the testing strip1.

Individuals as young as two can be tested by an adult, and the test is designed to be performed by anyone ages 14 and up. The smartphone app is now available on iOS and Android, which also provides step-by-step video instructions and timers. The app also has a feature where individuals can share their results with anyone in their contacts1.

EMMA International is here to provide full-circle solutions for all aspects of the MedTech industry, including apps and technology. Give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!

1FDA greenlights first smartphone-based home COVID-19 test. (2021, August 26). FierceBiotech. https://www.fiercebiotech.com/medtech/fda-greenlights-first-smartphone-based-home-covid-19-test

Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

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