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The FDA has authorized Roche’s cobas SARS-CoV-2 novel coronavirus diagnostic test for emergency use — the third emergency use authorization it has granted in its efforts to combat the outbreak. Read More
The diagnostic gives clinicians the ability to identify women that should undergo immediate further diagnostic procedures to prevent them from developing more advanced cervical disease. Read More
Third-party review organizations “shall not engage in the design, manufacture, promotion, or sale of devices” and must be impartial, the agency said. Read More
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