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The marketers falsely claimed that the device was approved by the FDA to diagnose and treat chronic, severe pain and reduce inflammation, the FTC said. Read More
The company said surgeons should “discuss the potential clinical implications and risks with symptomatic patients who received the affected implants.” Read More
The test is only authorized for the duration of the COVID-19 pandemic and the labeling must state that the test “has not been FDA approved or cleared,” the agency said. Read More