SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, has reported receipt of 510(k) regulatory clearance to market its latest version of Sonablate in the United States. Sonablate was the first HIFU device to receive regulatory authorization from the Food and Drug Administration (FDA) for the focused ablation of prostate tissue.

This improved version of Sonablate technology includes new and updated features such as: Tissue Change Monitoring (TCM), a tool that quantifies RF signals for changes in tissue composition following energy delivery; altered delivery sequences that, in combination with a new and more automated planning system, reduces overall procedure time by as much as 40%; and a modernized look and feel to the software interface.

“We worked diligently with the FDA to provide clinical data consistent with the requirements established in the de novo authorization SonaCare Medical received for Sonablate in 2015,” comments Dr. Mark Carol, chief executive officer. “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. Based on the adoption rates of Sonablate in the US in 2016, we expect the placements and acquisitions of our technology to grow dramatically in 2017, bringing this ground-breaking approach to a greater percentage of men in the US”

Since Sonablate received FDA clearance on October 09, 2015, there have been over 40 acquisitions of Sonablate technology, including placements at top-tier academic institutions located in California, Indiana, Maryland, New York, and Texas. Over 43 US physicians now offer HIFU prostate tissue ablation to their patients, and over 700 US patients have selected this minimally-invasive alternative to surgery or radiation.

SonaCare Medical is a world leader in minimally invasive focused ultrasound technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate, which has 510(K) clearance in the US under a De Novo regulatory classification; Sonablate 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the US; Sonatherm laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the US, has CE Marking and has obtained regulatory authorization in more than 30 countries outside the US.