IN THE NEWS | FDA Roundup: December 23, 2022

On December 23, the U.S. Food and Drug Administration provided an “at-a-glance summary” of news from around the agency, which included the over-the-counter EUA for ASSURE-100 Rapid COVID-19 At-Home Tests.

HPR | FDA Approves Emergency Use for First Rapid COVID-19 Test Developed in Hawaiʻi

Oceanit CEO, Dr. Patrick Sullivan joined Hawaii Public Radio host, Catherine Cruz to discuss the ASSURE-100 Rapid COVID-19 Test. Their ten minute discussion covered the research & development that went into ASSURE-100, the FDA EUA process, and what comes next.

Oceanit ASSURE-100 Dexter Poon

PRESS RELEASE | Oceanit Receives FDA Emergency Use Authorization for ASSURE-100 Rapid COVID-19 Tests

Oceanit receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the ASSURE-100 rapid antigen test for detection of COVID-19.