SonaCare Medical obtains FDA 510(k) clearance for updated HIFU prostate tissue ablation device

11 January 2017 (Last Updated January 11th, 2017 18:30)

The US food and Drug Administration has issued 510(k) regulatory clearance to SonaCare Medical’s latest version of HIFU prostate tissue ablation device, Sonablate.

SonaCare Medical obtains FDA 510(k) clearance for updated HIFU prostate tissue ablation device

The US food and Drug Administration has issued 510(k) regulatory clearance to SonaCare Medical’s latest version of HIFU prostate tissue ablation device, Sonablate.

Sonablate is designed for the precise ablation of prostate tissue using high-intensity focused ultrasound (HIFU) energy.

The physician creates a customised ablation plan based on real-time images of the prostate gland captured by Sonablate, they then use the device to deliver ablative ultrasound energy to targeted areas in the prostate gland.

The updated Sonablate technology has been incorporated with new features such as the tissue change monitoring (TCM), a tool that quantifies RF signals for changes in tissue composition after energy delivery; altered delivery sequences which, combined with a new and automated planning system, minimises the overall procedure time.

"The Sonablate technology has been adopted by academic institutions across the US states of California, Indiana, Maryland, New York, and Texas."

SonaCare Medical CEO Dr Mark Carol said: "We worked diligently with the FDA to provide clinical data consistent with the requirements established in the de novo authorisation SonaCare Medical received for Sonablate in 2015.

"We are appreciative of the efforts of the FDA to continue to advance the delivery of care for men who may benefit from prostate tissue ablation.”

The Sonablate technology has been adopted by academic institutions across the US states of California, Indiana, Maryland, New York, and Texas and has been applied as a minimally-invasive alternative to surgery or radiation on 700 US patients.


Image: Sonablate technology. Photo: courtesy of SonaCare Medical, LLC.