SonaCare Medical, a developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, announced 510(k) regulatory clearance 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,” according to a statement from SonaCare Medical.
This version of Sonablate technology includes features such as: Tissue Change Monitoring (TCM), a tool that quantifies radio frequency (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 percent; 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,” according to 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 U.S. 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 U.S.”
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 U.S. physicians now offer HIFU prostate tissue ablation to their patients, and over 700 U.S. patients have selected this minimally-invasive alternative to surgery or radiation.