Focal One focused ultrasound (HIFU) device secures FDA 510(k) clearance for the ablation of prostate tissue.- EDAP TMS SA.
EDAP TMS SA a global leader in therapeutic ultrasound, 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.
With Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and minimizes side effects of incontinence and impotence for patients. Using Focal One, surgeons can customize the HIFU procedure for each patient and each clinical condition.
Comment: Focal One received CE Mark approval in June 2013.
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