SonaCare Medical Receives FDA De Novo Clearance for Sonablate 450

October 16, 2015

Charlotte, N.C.-based SonaCare Medical has received de novo clearance from the FDA to market its Sonablate 450 in the U.S. for the ablation of prostate tissue.

Mark Carol, CEO of Sonablate, says there are several peer reviewed articles attesting to the device’s value in ablating the prostate while minimizing the occurrence of side effects.

Sonablate is the first high intensity therapeutic ultrasound device to receive FDA regulatory authorization for prostate tissue ablation, according to Sonacare.

The devicemaker expects to begin U.S. distribution of the product this month. — Michael Cipriano