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The granting of the CE mark for the Model JC-Tumour Therapy System [Chongqing (HAIFU) Hifu Technology Company Ltd.] marks a historic moment. This is the first time that the European safety standard has been awarded to a major medical therapeutic device from China.
The CE mark denotes absolute safety on two counts: of High Intensity Focused Ultrasound (HIFU) tumour treatment as a process, and of the Model JC-Tumour Therapy Device itself. Importantly, the rigorous clinical trials conducted in the UK corroborate the extensive data and information available in the Far East, where over 8,000 patients have already successfully received treatment.
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