SonaCare Medical said today that it won 510(k) approval from the FDA for the latest version of its high intensity focused ultrasound prostate tissue ablation device. The Sonablate device was the 1st of its kind to receive regulatory approval for the focused ablation of prostate tissue, according to SonaCare.
The next-gen version features a tool to quantify changes in tissue composition following treatment. It also boasts an altered delivery sequence in combination with an automated planning system that can reduce the overall procedure time by 40%, the Charlotte, N.C.-based company reported.
“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,” CEO Dr. Mark Carol said in prepared remarks. “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.”
The FDA approved the 1st version of Sonablate in October 2015. Just 1 year earlier, the FDA failed to recommend approval for the device, which propelled the company to reposition Sonablate to treat more aggressive stages of prostate cancer.
After SonaCare won FDA pre-market approval for the HIFU device, competitor EDAP (NSDQ:EDAP) pulled the de novo application for its Ablatherm HIFU.