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Medical Devices / Submissions and Approvals

FDA Clears EDAP TMS’s Focal One

June 11, 2018

EDAP TMS received 510(k) clearance for its Focal One device, used for the surgical removal of prostate tissue.

The device uses high intensity focused ultrasound to ablate prostate tissue and combines the use of MR and 3D biopsy data with real-time ultrasound imaging.

Using the device, urology surgeons can define precise contours around diseased tissue and remove a smaller portion of the prostate, lessening damage to healthy tissue and minimizing side effects.

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