Echotherapy equipment developer Theraclion has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) for its Echopulse high-intensity focused ultrasound device.
The IDE will allow Theraclion to proceed with a study to evaluate Echopulse for the treatment of breast fibroadenoma. The study will be conducted in collaboration with the University of Virginia and will include 20 patients. It is the first phase of Theraclion's application to the FDA for marketing clearance, according to the firm.
Echopulse is already sold in Europe. Theraclion also intends to market the device in the Middle East, Africa, Asia, and Latin America, and it expects to be able to sell it in China and the U.S. by 2015 and 2017, respectively.
