FDA clears Dilon Diagnostics' GammaLoc lesion-localization system

Dilon Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its lesion-localization system for molecular imaging biopsy guidance.

GammaLoc(®), pronounced "gamma-loke", is a complementary technology to Dilon's cornerstone product, the Dilon 6800(®) Gamma Camera. The GammaLoc(®) (GL) system will help doctors accurately locate breast lesions and enable gamma-guided biopsies, particularly useful for patients that have findings on the Dilon system that are not revealed with other imaging modalities.

The GammaLoc(® )system utilizes a CorreLocator(TM) paddle and a StereoView(TM) imaging collimator system - a technique similar to that used in stereotactic X-ray localization, and the GammaLoc(®) software calculates the specific location of the suspect lesion. The compact design allows for breast biopsies with optimal patient comfort; and the entire system is small and portable, allowing physicians to perform molecular imaging guided biopsy procedures anywhere on site.

"Thanks to the superior performance of the Dilon 6800 camera combined with this new biopsy-guidance capability, physicians will find it easier to locate suspicious lesions seen with molecular breast imaging, greatly facilitating and expediting the biopsy process," said Robert Moussa, President and CEO of Dilon Diagnostics. "This recent innovation helps physicians improve patient management and confidently deliver faster, more accurate results to their anxious patients."