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. under a De Novo regulatory classification 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 reflect "off-label" indications or uses performed outside of the United States.

HIFU company

Contact

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      Charlotte, NC 28216

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Latest News

11 January 2017

Charlotte, NC (PR Newswire) January 11th, 2017 - SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its...

05 October 2016

Charlotte, NC (PR Newswire) Oct 5th, 2016,  SonaCare Medical, leading developer and manufacturer of High Intensity Focused Ultrasound (HIFU) Technologies, reports over 40 acquisitions of Sonablate® technology since the device...