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news.Naviscan, a developer and marketer of high-resolution positron emission tomography scanners, has received the FDA 510(k) clearance for Stereo Navigator, its biopsy-guidance feature designed exclusively for use with its high-resolution organ-specific positron emission tomography scanner. The scanner's breast application is positron emission mammography.
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Stereo Navigator, the positron emission mammography-guided biopsy accessory, is indicated for the localization of lesions in female breasts, as identified on a positron emission tomography (PET) image. This guidance system will now enable physicians to guide compatible interventional devices towards abnormalities visible on positron emission mammography, the company said.
The accessory uses a stereotactic frame fixed between the scanner’s paddles to guide the insertion of a compatible interventional device into the breast. Accurate targeting is said to be possible due to the high-resolution 3-D tomographic images acquired. Localization of the abnormality is verified using a PET-visible line source that is inserted into the needle track allowing the user to confirm trajectory and position.
Paul Mirabella, chairman & CEO of Naviscan, said: “The strength of our high-resolution PET scanner has always been the ability to resolve suspicious lesions down to 2mm. Now we can also offer biopsy guidance, providing physicians with the all important pathological confirmation to determine the optimal course of treatment.”