The invention comes from InspectIR Systems, a small company based in Frisco.“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement Thursday., the company worked with the FDA for months before learning of the approval last Thursday.
The test comes in a case weighing about 40 pounds, the station reported, and can yield a result in less than three minutes. the device was more than 91% accurate detecting positive cases and more than 99% accurate with negative samples.it could take between 10 and 12 weeks for the device to hit the market. The company will aim to produce about 100 devices a week, according to the FDA.