Medicare announced coverage for the Dexcom G7 continuous glucose monitor, as well as a breast cancer indication for Natera Inc.’s Signatera; the FDA authorized a new monkeypox test; the FDA issued a warning letter to a Texas masks firm; and a new report says NIST labs are failing behind. 

The US Food and Drug Administration has taken additional steps to ensure mutations of the COVID-19 virus do not negatively impact the efficacy of tests.

Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.

The US government is helping Sonica develop ADAM, a patch monitor that tracks the user's breathing patterns and other physiologic signals to detect SARS-CoV-2 infections.