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FDA Approves Breast Specimen Radiography with Tomosynthesis


Kubtec’s newly approved breast specimen radiography system is the first and only system with tomosynthesis technology, Kubtec announced.

The United States Food & Drug Administration (FDA) has approved MOZART with TomoSpec, Kubtec’s breast specimen radiography system with tomosynthesis technology.[[{"type":"media","view_mode":"media_crop","fid":"28310","attributes":{"alt":"Kubtec's MOZART with TomoSpec","class":"media-image media-image-right","id":"media_crop_1812294781991","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"2854","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 260px; width: 200px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":" ","typeof":"foaf:Image"}}]]

According to a release, MOZART with TomoSpec is the first and only breast specimen radiography system with tomosynthesis technology. The comprehensive analysis of excised breast tissue in a specimen radiography system like MOZART with TomoSpec may reduce re-excision and patient call back rates, Kubtec said. High resolution image slices are acquired in less time, resulting in shorter surgeries, less anesthesia, and a lower risk of infection, Kubtec said.

The mobile MOZART with TomoSpec is useful for radiology, pathology, or surgery, and images can be viewed with wireless transmission to PACS or on the system’s monitor.

“MOZART with TomoSpec allows 3D margin assessment in one step, without turning and repositioning the specimen container,” Vikram Butani, president, Kubtec, said in a release. “The system captures an entire data set in less time than it takes to acquire multiple 2D images. This is critical for delivering a higher level of care to women undergoing surgery for breast cancer.”

MOZART with TomoSpec will reduce risk, enhance throughput, and provide superior images efficiently and easily for surgeons, radiologists, pathologists, and health care facilities, Kubtec said.

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