A molecular breast imaging system for guiding needle biopsies got cleared by the FDA December 14, according to a statement from Dilon Diagnostics, the company that makes the product.

Called the GammaLoc System, the device is an accessory to Dilon's Gamma Camera 6800 and helps doctors calculate lesion location and depth for automated needle biopsies. It uses what Newport News, Va.-based Dilon has dubbed a CorreLocator paddle and a StereoView imaging collimator to perform a procedure similar to stereotactic X-ray biopsy, giving 20-degree stereo views of both the right and left sides of the breast.

BREAST SPECIFIC GAMMA IMAGING

Breast specific gamma imaging is a nuclear medicine technique that uses a compound made from the isotope technetium known as Tc-Sestamibi to illuminate tumors in the breast. Nancy Morter, a spokeswoman for Dilon, says independent studies suggest that BSGI, when used as a pre-surgery planning tool, can detect 10 percent more cancerous lesions than mammography or ultrasound alone.

"This test, BSGI, is generally more sensitive and specific than ultrasound, and will often pick things up not found in other modalities," she tells DOTmed News.

What's more, Morter says Dilon's system, although designed with the breast in mind, can also be used for thyroid and parathyroid molecular imaging exams -- procedures which also use Tc-Sestamibi to light up tumors.

Four GammaLoc Systems have already been sold in the last couple of weeks, according to Dilon. "We're going into breast imaging centers and hospitals in the first quarter of the year," Morter says.

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