On Apr. 15, 2020, Todos Medical announced the FDA has accepted Todos Medical’s application for Medical Device Establishment Registration. This designation allows Todos to import medical devices for commercial sale that have been manufactured by non-U.S. entities.

Todos has entered into agreements to import point-of-care antibody fingerprick blood-based testing kits and COVID-19 digital PCR-based testing kits from oral/nasopharyngeal swabs, saliva and stool, as well as automated extraction lab equipment to support a newly established risk stratification screening and reflex high throughput diagnostic testing paradigm that it believes will allow for greater access to highly accurate testing in the U.S.