The U.S. FDA granted marketing authorization for Healgen Scientific LLC’s Rapid Check COVID-19/Flu A&B antigen test.

The U.S. FDA posted a series of de novo decisions Sept. 9, including a digital diagnostic for chronic kidney disease progression by Renalytix AI Inc., of New York, and a digital therapy device for management of fibromyalgia symptoms by Swing Therapeutics Inc., of San Francisco.

The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.