The company's launch of the accessory follows U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded use of ergo for indications such as the evaluation of lesions in the breast and other small body parts. The clearance enables ergo to be used as an adjunct to mammography or other primary breast imaging methods, according to the company.
The MBI accessory includes a specialized breast imaging assembly and breast-mode software to capture normal mammographic views for direct correlation with the patient's mammogram. The open design of ergo provides easy access for hands-free breast positioning on patients who can be seated, standing, or lying down during the examination, Digirad said.
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