Visby Medical said that it has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for its second-generation point-of-care sexual health test.

QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).

The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.

The Construction of Mindray, Biotime and Nanomicro R&D Bases Begins

The funding will be used to provide purchase commitments to manufacturers so they can scale up test production.

Meridian Bioscience announced on Wednesday that its Revogene SARS-CoV-2 test has received Emergency Use Authorization from the US Food and Drug Administration.

Recently, South Korean idol Song Joong Ki endorsed SD BIOSENSOR, an in vitro diagnostic company, sparking heated discussions in the IVD industry.