The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home. The agency since then has authorized five at-home COVID-19 tests for emergency use since the beginning of the pandemic. The kits are made to take a sample […]
Cue Health
First OTC molecular test for COVID-19 gains FDA nod
The FDA today issued its first emergency use authorization for a molecular COVID-19 diagnostic test for at-home use without a prescription. The Cue Health COVID-19 Test for Home and Over The Counter (OTC) use is a molecular nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus in the nostrils. The authorized […]
MedTech 100 roundup: Industry continues its ascent
Stocks in the medtech industry maintained their upward trajectory, topping last week’s peak with yet another rise to new heights. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 95.66 (Oct. 16), marking a 0.6% gain from the 95.05 points registered at the end of […]
Cue Health lands $481M from HHS for COVID-19 test
The federal government has awarded startup Cue Health $481 million to increase domestic production capacity of point-of-care testing for COVID-19. The money from the Department of Health and Human Services and the Department of Defense will enable San Diego, Calif.-based Cue to manufacture 100,000 COVID-19 test kits per day by March 2021, including 6 million […]
