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Focal One receives FDA clearance

Focal One receives FDA clearance
EDAP TMS has announced that it has received 510(k) clearance from the FDA for its Focal One device for the ablation of prostate tissue. The Focal One high intensity focused ultrasound (HIFU) device is the first medical apparatus designed specifically for focal treatment of the prostate. Focal One fuses MR and 3D biopsy data with real-time ultrasound imaging, which allows urologists to view integrated, detailed 3D images of the prostate on a large monitor and direct high intensity ultrasound waves to ablate the targeted area.
13th June 2018

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