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France's EDAP receives US FDA clearance for medical device

EDAP TMS SA said the U.S. Food and Drug Administration granted 510(k) clearance to its Focal One device for removing prostate tissue.

The French device maker said the Focal One high-intensity focused ultrasound device is the first medical apparatus designed specifically for focal treatment of the prostate.

The device allows urologists to view detailed 3D images of the prostate and direct high-intensity ultrasound waves to remove the targeted area.