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FDA grants de novo clearance to Sonablate 450 for prostate tissue

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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.

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