FDA grants de novo clearance to Sonablate 450 for prostate tissue

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA granted de novo clearance to SonaCare Medical LLC to market the Sonablate 450 in the U.S. for the ablation of prostate tissue.

Sonablate is the first High Intensity Therapeutic Ultrasound device to receive FDA regulatory authorization for prostate tissue ablation. SonaCare expects to begin U.S. distribution this October.

Sonablate is the Company’s second medical device to receive U.S. FDA regulatory authorization, complementing the 510(k) cleared Sonatherm laparoscopic HITU ablation device.

YOU MAY BE INTERESTED IN

A year ago, when he was sworn in as director of the National Cancer Institute, Anthony G. Letai set a goal: Reassure cancer researchers that the institute will keep a steady course aimed at finding treatments for cancer.
Michael R. Caputo, a cancer survivor and a Republican political operative with a wide-ranging resume, was named to the President’s Cancer Panel, a board formed under the National Cancer Act to monitor the National Cancer Program and report to the president about “barriers to progress in reducing the burden of cancer.”
For over two decades, the ASCO Genitourinary Cancers Symposiumhas stood as the premier global event that has helped advance cancer science and transform care. The 2027 Symposium will continue this legacy from Feb. 11–13 in San Francisco by bringing together the largest international audience in GU oncology to help define tomorrow’s standards of care. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login