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The Genius TM Digital Diagnostics System with the Genius™ Cervical AI algorithm includes the Genius TM Digital Imager, Genius™ Image Management Server (IMS), the Genius™ Review Station, and the Genius™ Cervical AI algorithm. The Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended for the creation and viewing of digital images of scanned ThinPrep® Pap Test glass slides. Objects of interest selected by the Genius™ Cervical AI algorithm from the scanned digital image are presented in a gallery format next to the image of the whole cell spot on the Genius™ Review Station for review and interpretation. The Genius Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions) and carcinoma, as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology1. After digital review with the Genius Cervical AI algorithm, if there is uncertainty in the diagnosis, then direct examination of the glass slide by light microscopy should be performed. Digital images from the Genius Digital Diagnostics System with the Genius™ Cervical AI algorithm should be interpreted by qualified cytologists in conjunction with the patient's screening history, other risk factors, and professional guidelines which guide patient management.

The Genius Digital Diagnostics System includes, Genius Digital Image. Management Server, Genius Review Station(s), and Genius Cervical AI algorithm, as shown in Figure 1 below.

The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination. It is intended for lesion location for biopsy while the patient is in the prone position to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).

The Affirm Prone Biopsy Table is a mammographic x-ray system intended for lesion location while the patient is in the prone position. The subject device will be capable of both 2D and 3D imaging methods to calculate the target location. The system localizes suspicious lesions, as determined through prior mammographic examinations, using either stereotactic or tomosynthesis techniques. The system then affords a physician the capacity of performing vacuum assisted or needle core biopsy, or wire localization of the lesion. Localization can be accomplished either via conventional 2D stereotactic imaging, or by use of a 3D data set. With the 3D data set, the image plane or "slice" most fully containing the suspected lesion is chosen by the physician from the data set to compute the lesion depth within the breast.