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Cardiovascular devices often approved by FDA without high-quality studies, study suggests

Cardiovascular devices often approved by FDA without high-quality studies, study suggests

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Pre-market approval by the FDA of cardiovascular devices is often based on studies that lack adequate strength or may have been prone to bias, according to a new study. Researchers found that of nearly 80 high-risk devices, the majority received approval based on data from a single study.

Sourced from: ScienceDaily: Health & Medicine News

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