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The FDA has taken Genomic and Healthspek to task for marketing direct-to-consumer tests that appear to meet the criteria of medical devices, but have not been cleared by the agency. Read More
Devicemakers may get a reprieve as part of a bill passed by the U.S. House and Senate on Friday that included a provision to suspend the 2.3 percent medical device excise tax for 2016 and 2017. President Barack Obama signed the year-end omnibus appropriations bill late Friday. Read More