SonaCare Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for the updated high-intensity focused ultrasound (HIFU) prostate tissue ablation device.
The company can now market its latest version of Sonablate in the US.
Sonablate is claimed to be the first FDA approved HIFU device for the focused ablation of prostate tissue.
The new version of Sonablate technology includes advanced features such as tissue change monitoring (TCM), which quantifies RF signals for changes in tissue composition following energy delivery.
Sonablate will acuire real-time images of the prostate gland, helping physicians to create a customized ablation plan for each patient.
Later, the physician will use Sonablate to deliver ablative ultrasound energy to targeted areas in the prostate gland.
The HIFU procedure, which will take between two to four hours depending on the size of the prostate, can be carried out by using general anesthesia or an epidural and IV sedation.
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 authorization 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 company also produces Sonatherm laparoscopic HIFU surgical ablation system, which received FDA clearance and CE mark approval.
SonaCare Medical is engaged in the development of ultrasound related technologies, which can be used in procedures to treat a range of medical conditions.
Image: SonaCare Medical’s latest version of Sonablate HIFU prostate tissue ablation device. Photo: courtesy of PRNewsFoto/SonaCare Medical, LLC.