FDA has granted 510(k) clearance to Naviscan for its biopsy-guidance feature designed exclusively for use with its high-resolution positron emission mammography (PEM) scanner.
Stereo Navigator, the PEM-guided biopsy accessory, is indicated for the localization of lesions in female breasts, as identified on a PET image. The guidance system will now enable physicians to guide compatible interventional devices towards abnormalities visible on PET, according to the San Diego-based company.
"The strength of our high-resolution PET scanner has always been the ability to resolve suspicious lesions down to 2 mm," said Paul Mirabella, chairman and CEO. "Now we can also offer biopsy guidance, providing physicians with the all important pathological confirmation to determine the optimal course of treatment."
The accessory uses a stereotactic frame fixed between the scanner's paddles to guide the insertion of a compatible interventional device into the breast. It is compatible with the following breast biopsy systems: Mammotome from Ethicon Endo-Surgery; ATEC from Hologic, and EnCor from SenoRx, Naviscan said.