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news.Misonix has received 510(k) clearance from the FDA to market its Sonatherm 600i high intensity focused ultrasound soft tissue ablation system in the US.
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According to the company, the Sonatherm 600i system will be used to ablate certain soft tissue lesions, excluding the prostate gland, in general surgery.
The company expects to arrange for a number of leading physicians from the US to observe the Sonatherm 600i in clinical practice at the University of Vienna hospital prior to performing surgical procedures in the US. Clinical data collection will take place at several sites in the US prior to commercial sale of the product.
Misonix’s Sonatherm 600i system adds imagery and motion capability. To date, the two Sonatherm systems are said to be the only 600i high intensity focused ultrasound (HIFU)-based soft tissue ablation systems that have received the FDA clearance for general surgery.