Dilon Diagnostics Gamma-Guided Localization System Cleared by FDA


Dilon Diagnostics announced 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® 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™ paddle and a StereoView™ 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.