March 5, 2019

FDA issues Safety Communication on using surgical robots in women’s health

By: Judy Mathias
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Editor’s Note

The Food and Drug Administration (FDA) on February 28 issued a Safety Communication on the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer in women.

The FDA cited limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be linked to diminished long-term survival.

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