A device used in Europe to treat prostate cancer with lower rates of erectile dysfunction raised concerns from U.S. regulators over data the company says shows it prevents the disease’s return.
The device, called Ablatherm, is manufactured by EDAP TMS SA (EDAP), a French company. It’s an alternative to traditional surgical and radiation treatments, and uses a robotic arm to insert a high-intensity, focused ultrasound device that heats and kills cancer cells. The Food and Drug Administration said it will convene a panel of outside advisers on July 30 to discuss the risks and benefits of the device before the agency decides whether to approve it.
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