Results were presented this week at the 5th International Symposium on Focused Ultrasound (FUS), held August 28 – September 1, 2016 in Bethesda, USA. Theraclion also announced that the U.S. Food and Drug Association (FDA) cleared Theraclion’s request for an Investigational Device Exemption (IDE) for breast fibroadenoma, which will be developed via the 513(f)(2) pathway.
Hosted by the Focused Ultrasound Foundation, the International Symposium on Focused Ultrasound is the single most significant international conference dedicated to high-intensity focused ultrasound (HIFU) therapy, bringing together every year the leading experts, researchers and practitioners in the field, alongside key players in the industry.
“Results from the presented studies continue to demonstrate the very good efficacy and tolerability of echotherapy (US-guided High Intensity Focused Ultrasound – HIFU) as a non-invasive ablative technique for both symptomatic breast fibroadenoma and benign symptomatic thyroid nodule indications,” commented Michel Nuta, M.D., Chief Medical Officer of Theraclion.
David Caumartin, CEO of Theraclion added, “Through additional clinical trials, including now in the U.S., we believe we will continue to demonstrate the value of the Echopulse® system for physicians and their patients.”
As part of this year’s FUS symposium, the latest results were presented from three studies on the treatment of breast fibroadenoma and two on the treatment of thyroid nodules.
