ROCKVILLE, Md—The FDA has approved the marketing of the Optical Biopsy System (SpectraScience, Inc.), a laser-based technique designed to assist physicians in deciding whether certain colon polyps are precancerous and should be removed. The company chose the trademark name Optical Biopsy System after the FDA refused to accept the name "Virtual Biopsy System" for its product.
The adjunct diagnostic system operates through an endoscope and can be used during either sigmoidoscopy or colonoscopy. It consists of a laser, an optical fiber, analytical software, and a user-interface console.
Laser light is transmitted through the optical fiber and aimed at a suspicious polyp. The polyp absorbs the light and re-emits it through the fiber to a computer, where computations performed by the software indicate whether the polyp has the potential to become malignant. The analysis takes less than 1 second.
The Optical Biopsy System is meant, "to evaluate polyps less than 1 cm in diameter that the physician has not already decided to remove," the FDA said in announcing its approval of the device. "When used by physicians who base removal of polyps on their visual assessment, the device helps them to decide which polyps should be removed and sent for microscopic examination and which can safely be left alone. It is not intended to be used as a stand-alone device and should not be used to replace the physician's judgment in the removal of colonic polyps."
Use of the Optical Biopsy System is restricted to physicians trained in endoscopy and in the use of the new system.
The FDA based its approval of the device on clinical studies conducted by SpectraScience and on the recommendation of the Gastroenterology and Urology Devices panel of its Medical Devices Advisory Committee.
Study Results
