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Blood Irradiation Devices May Be Class III, FDA Panel Says

 
• By Elizabeth Orr

The FDA radiological devices advisory panel said that there wasn’t enough evidence backing the use of irradiation to prevent metastasis in the blood of cancer patients, especially given the treatment’s known risks.

Human red blood cells
• Source: Shutterstock

Blood irradiators used to prevent cancer metastasis in the blood may need to be regulated under the US Food and Drug Administration’s highest-risk class III due to limited information, an agency advisory panel concluded at its 7 November meeting.

The radiologic devices advisory panel convened to make recommendations on the categorization of “blood irradiator devices intended to be used...

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