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Plus deals involving Astellas/Menarini, Maruho/Fortress Biotech, Zenas/Bristol Myers Squibb, Huadong Medicine/MC2 and more.
News We’re Watching – Medicare Covers Dexcom CGM; New Mpox EUA; $106M Patent Verdict Against Medtronic
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.
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