MINNEAPOLIS, Minn., Nov. 20 -- SpectraScience Inc.'s pre-market approval application has been accepted by the US Food and Drug Administration. SpectraScience's optical biopsy laser system will be marketed under the name Optical Biopsy System since the FDA turned down the original name, Virtual Biopsy System, that was submitted by the company.
The system is used by physicians to help determine whether tissue in the colon is normal, pre-cancerous or cancerous without having to remove the tissue from the body. Multicenter clinical trials have demonstrated an improvement in the physician's diagnostic accuracy when the system was used, the company said.