FDA Schedules Review of SpectraScience PMA
MINNEAPOLIS, Nov. 2 -- SpectraScience Inc. reported that the company's Pre-Market Application (PMA) submission for its optical biopsy system utilizing laser-induced fluorescence is scheduled for panel review by the US Food and Drug Administration on November 19, 1999. The PMA will be reviewed by the Gastroenterolgy and Urology Devices Panel of the FDA's Medical Devices Advisory Committee, which will provide advice and recommendations to the FDA on regulatory issues pertaining to SpectraScience's submission. The company noted that the panel review usually serves as the last significant regulatory hurdle before the FDA provides clearance to market a medical device.
Chet Sievert, SpectraScience's president and CEO, stated, I am extremely pleased that we have reached this most important milestone in the FDA approval process. Our upcoming panel review is the culmination of 18 months of extremely hard work and unflinching dedication on the part of all SpectraScience employees, our clinical investigators, and our medical and scientific advisors.
MORE FROM PHOTONICS MEDIA