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Mar 27, 2023Cue Health's Covid
Apr 24, 2023By Sabela Ojea
Cue Health said Tuesday that its Covid-19 molecular test has received a De Novo marketing authorization from the U.S. Food and Drug Administration.
Shares rose 12% Tuesday to close at 59 cents.
The healthcare technology company said its Covid-19 molecular test, which can be used at home or at point-of-care settings, delivers results in 20 minutes to connected mobile smart devices. Covid-19 molecular tests detect genetic material called RNA from the virus.
A De Novo request gives a marketing pathway to classify new medical devices for which certain controls provide reasonable assurances of safety and effectiveness.
Write to Sabela Ojea at [email protected]; @sabelaojeaguix
Corrections & Amplifications
This article was corrected at 7:39 p.m. ET to reflect that Cue Health shares rose 12% Tuesday to close at 59 cents. The original version incorrectly said the rise was in after-hours trading.
Cue Health shares rose 12% Tuesday to close at 59 cents. "Cue Health's Covid-19 Test Gets FDA Marketing Authorization," at 4:16 p.m. ET, incorrectly said the rise was in after-hours trading.
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