Medical Device Makers Play the FDA Waiting Game
Misonix may be based in Farmingdale, but you’ll have to board a plane to use its prostate cancer-treating ultrasound device. Although the firm makes ultrasound devices approved in the U.S. to treat various diseases, its prostate cancer treatment device is approved by regulators in Europe — and not by the Food and Drug Administration. And despite the 6,000 procedures that have been performed in Europe (for the past three years) and in Japan (since 1997), Misonix thinks it’s at least three years from getting the green light in the United States.
Long Island Business News