Flawed data behind regulation of high-risk women's health devices

Some high-risk medical devices used in obstetrics and gynecology were approved by the FDA based on flawed data and were not effective in clinical trials, according to a recent study. The investigators assessed the regulation of women's health devices approved by the FDA in the last 15 years. The agency's approvals should be based on clinical studies more rigorous than currently required, both before and after the devices go to market, the authors said.

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