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Medical Devices / Regulatory Affairs

FDA Issues Warning to QLRAD Netherlands

Sept. 15, 2017

The FDA moved to block the importation and sale of a Dutch device designed to immobilize the prostate during radiation treatments to target it more accurately and minimize damage to surrounding tissue.

QLRAD Netherlands, maker of the RectalPro Endorectal Balloon, did not apply for the required premarket approval or investigational device exemption for the balloon, the FDA said in a warning letter.

QLRAD promoted the device for use with radiation therapy on its web site and in brochures distributed at medical conferences in San Antonio and Boston, the FDA said.

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