Braster

U.S. FDA Food and Drug Administration

We would like to inform that BRASTER® company uses the contact thermography method in its BRASTER®PRO certified medical device. The method as such is not used for independent diagnosis of breast cancer, but it is an additional complementary method to such diagnostic methods as mammography or ultrasound.

The BRASTER®PRO examination cannot be used as a stand-alone diagnostic method. BRASTER®PRO is a class IIa medical device certified by the notified body TUV Nord Polska. Under the issued certificate of conformity, the product was marked with the CE mark and placed on the market in the territory of the European Union.

Detailed information about the issued message can be found on the websiteFDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication
Information is available in English.

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