Dilon Diagnostics, GE Healthcare get FDA approval for Discovery NM 750b biopsy accessory
Dilon Diagnostics and GE Healthcare have received approval from the US Food and Drug Administration (FDA) for the molecular breast imaging (MBI) localization accessory for breast biopsy.
Earlier this month, Dilon signed an exclusive agreement to supply GE's Discovery NM750b molecular breast imaging system in North America.
The MBI localization accessory, which is a complementary technology to the Discovery NM750b system, will accurately locate lesions in three dimensions in the breast by using information derived from stereotactic pairs of two-dimensional images.
The accessory has been developed to offer guidance for interventional purposes such as biopsy and pre-surgical.
Discovery NM 750b breast imaging system will measure and image the distribution of selected single photon emission radioisotopes in the human body to assist in the evaluation of lesions.
The system will enable clinicians to measure a wide range of patients, including those with dense breast.
The Discovery NM750b and breast biopsy accessory are exhibiting at the RSNA conference in Chicago, which is being held from27 November to1 December.
Dilon Diagnostics produces and markets medical imaging solutions across the globe. Dilon molecular imaging system can be used to image small body parts, such as the breast, thyroid, parathyroid and bone.
GE Healthcare offers products ranging from medical imaging, software and IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions.