> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Edap Focal One Cleared for Ablating Prostate Tissue
- URL: https://www.fdaweb.com/edap-focal-one-cleared-for-ablating-prostate-tissue/
- Published: 2018-06-08T12:00:00.000Z
- Updated: 2026-09-15T00:11:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141635

FDA has cleared an Edap TMS 510(k) for its Focal One device for ablating prostate tissue. The high-intensity focused ultrasound device is the “first medical apparatus designed specifically for focal treatment of the prostate,” the company says. “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,” it says. The device allows surgeons to map precise contours around diseased tissue and ablate small portions of the prostate to lessen damage healthy tissue and minimize side effects of incontinence and impotence for patients, the company adds.