Virtual diagnostic platform Cue Health has received De Novo authorization from the FDA for its Cue Covid-19 Molecular Test, making it the first FDA-authorized home-use Covid-19 test. De Novo authorization is a regulatory pathway provided by the FDA for the approval of new medical devices. It is used when the device does not have a legally marketed predicate device to which it can be compared.
The Cue Covid-19 Molecular Test provides rapid results and detects all known Covid-19 variants of concern. The test delivers results in 20 minutes to connected mobile smart devices and has an accuracy of 98%. It can be used at home or at point-of-care settings. The test integrates with mobile smart devices and is part of Cue Care, which offers personalized access to diagnostic tests and Telehealth consultations.
By using this site, you agree to allow SPEEDA Edge and our partners to use cookies for analytics and personalization. Visit our privacy policy for more information about our data collection practices.