Peer Reviewed Library

Regulatory Statement:

The clinical publications that you will obtain access to after reading and acknowledging this disclaimer by clicking the link below may refer to the following devices manufactured by SonaCare Medical: Sonablate®, Sonablate® 500 and Sonatherm®. These publications may include information on uses of these devices that have not been approved or cleared by the United States Food and Drug Administration.

Sonablate® 500 has CE Marking and has obtained regulatory authorization in more than 50 countries outside the U.S.

Sonablate® has 510(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Sonatherm® laparoscopic HIFU surgical ablation system has 510(K) clearance in the U.S., CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S. Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. Sonatherm is not to be used to spare intervening tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Disclaimer:

*By clicking the "Agree and Continue" button below, I confirm that I have requested clinical information about SonaCare Medical devices. I acknowledge that information presented in these articles may be related to devices that are not cleared or approved for use in the United States, international indications for use and device use outside of the United States.

HIFU company

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Latest News

26 September 2017

Medicare recognizes HIFU prostate ablation as a device-intensive procedure driving new ASC payment going into effect on or after October 1, 2017 CHARLOTTE, N.C., Sept. 20, 2017 /PRNewswire/ -- SonaCare...

29 August 2017

CHARLOTTE, N.C., August 30, 2017 – SonaCare Medical, the leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announces today the successful collaboration with BK Ultrasound, achieving compatibility...