SpectraScience, a San Diego-based medical device company, has reported that FDA has conducted an unannounced inspection of its facility. No Form 483 was issued and SpectraScience remains in compliance with all regulations.
SpectraScience said that it holds approximately 60 patents worldwide that have been issued or are pending on its WavSTAT Optical Biopsy System and Luma Cervical Imaging Systems.
Jim Hitchin, CEO of SpectraScience, said: “The inspection is part of an ongoing review of our Class III facility where we manufacture our patented and proprietary WavSTAT Optical Biopsy System and LUMA Cervical Imaging System. Both systems are used by physicians as an adjunctive tool to assist in determining if tissue is normal, pre-cancerous, or cancerous within seconds.
“The WavSTAT System is currently approved by the FDA for use in the colon. A new application for detecting pre-cancers in the throat, sometimes called Barrett’s esophagus, is being tested in clinical trials. Cancer of the esophagus is more than 90% fatal and may develop as a result of chronic heartburn or GERD. Esophageal cancer is growing six times faster than all other cancers.
“This is our second unannounced inspection in two years. No adverse observations were made in either visit. I believe this is an excellent indicator of the quality system we have developed and the standards we hold ourselves to in manufacturing our products.”