Focused ultrasound treatment for the prostate is now available in the United States. Two systems for destroying diseased prostate tissue are now approved by the Food and Drug Administration.

FDA Approved square

Focused Ultrasound Therapy

Focused ultrasound is an early-stage, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with BPH. This novel technology focuses beams of ultrasound energy precisely and accurately on targets in the body without damaging surrounding normal tissue. Where the beams converge, the ultrasound produces precise ablation (thermal destruction of tissue) enabling BPH to be treated without surgery.

The primary options for treatment of BPH include medication and invasive surgery.

Outside Approval Square

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications and lower cost.


  • Focused ultrasound is noninvasive, so it does not carry added concerns like surgical wound healing or infection.
  • Focused ultrasound can reach the desired target without damaging surrounding tissue.
  • It can be repeated, if necessary.

Clinical Trials Square

Clinical Trials

A clinical trial in Finland is looking at a transurethral approach for several prostate conditions, including BPH. 

See a full list of BPH clinical trials > 

See a list of treatment sites >
See a list of clinical trials sites >
See a list of laboratory research sites >

Regulatory Approval and Reimbursement

There are two focused ultrasound systems approved in the US for the ablation (destruction) of prostate tissue: SonaCare Medical and EDAP-TMS. Both of these use the transrectal approach. A transurethral approach is manufactured by Profound Medical, and is approved in Europe but not in the US.

Treatment for BPH is approved in the US, Canada, China, Europe, India, Japan, Korea, Middle East, Russia, and South America. Insurance coverage varies, and many US companies may not cover this procedure.

Notable Papers

Aoun F, Marcelis Q, Roumeguère T. Minimally invasive devices for treating lower urinary tract symptoms in benign prostate hyperplasia: technology update. Res Rep Urol. 2015 Aug 19;7:125-36. doi: 10.2147/RRU.S55340. eCollection 2015.

Khokhlova VA, Fowlkes JB, Roberts WW, Schade GR, Xu Z, Khokhlova TD, Hall TL, Maxwell AD, Wang YN, Cain CA. Histotripsy methods in mechanical disintegration of tissue: towards clinical applications. Int J Hyperthermia. 2015 Mar;31(2):145-62. doi: 10.3109/02656736.2015.1007538. Epub 2015 Feb 24.

Thiruchelvam N. Surgical therapy for benign prostatic hypertrophy/bladder outflow obstruction. Indian J Urol. 2014 Apr;30(2):202-7. doi: 10.4103/0970-1591.126907.

Roberts WW. Development and translation of histotripsy: current status and future directions. Curr Opin Urol. 2014 Jan;24.

Click here for additional references from PubMed

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