"The FDA has granted an Emergency Use Authorization for the first COVID-19 diagnostic test that detects chemicals in breath samples associated with the SARS-CoV-2 virus," the regulator's website said in a statement.
The test was 91.2% effective in a study of 2409 people.
It is noted that the test is carried out using a device the size of hand luggage, the result will be ready in less than three minutes.
Earlier, Pfizer spoke about the effectiveness of COVID-19 pills against the omicron strain.