FDA clears Misonix HIFU soft tissue ablation system

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Misonix, a developer of minimally invasive ultrasonic medical device technology, has received 510(k) clearance from the FDA to market its Sonatherm 600i high intensity focused ultrasound (HIFU) soft tissue ablation system in the United States.

The FDA has indicated that Sonatherm can be used to ablate certain soft tissue lesions, excluding the prostate gland, in general surgery, according to the company.

The Farmingdale, N.Y.-based Misonix said its Sonatherm 600i System is an updated version of its Sonatherm 600 System that received FDA clearance in January 2006, adding imagery and motion capability.

The Sonatherm 600i utilizes HIFU to ablate tissue intra-operatively or laparoscopically from a focal point back to the surface of the tissue of the lesion, eliminating the need to puncture or otherwise invade the tissue mass, the company said.