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FDA Approves Optical Biopsy System for Assessing Colon Polyps

FDA Approves Optical Biopsy System for Assessing Colon Polyps

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

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