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El FDA aprueba el sistema del tomo del espécimen del pecho de Kubtec
Kubtec announced yesterday that its breast specimen radiography system with tomosynthesis technology — MOZART with TomoSpec — received FDA approval. The company stated that it's the first and only breast specimen radiography system that combines 2-D and 3-D imaging to evaluate excised breast tissue.
"It was the natural process of things as mammography went to tomosynthesis — the next step with excised breast tissue was to be able to provide the same level of imaging capability for the excised breast tissue as was available for breast and mammography," Vikram Butani, president of Kubtec, told DOTmed News.
When excising breast tissue, surgeons have to get enough healthy tissue surrounding the cancer to ensure that no cancer is left inside of the patient. But when the tissues are removed from the body, it is difficult to determine the original orientation.
"Because of that, it is a challenge to make sure that the 2-D image can give you the information you need to confirm that you've got the entire cancer out," said Butani. The best you can do with the 2-D technology is take two images — take one image then turn the box 90 degree and take another — but it's not accurate enough and it takes a lot longer than 3-D, he added.
The 3-D technology eliminates that challenge because the images it generates allow the surgeon to see the 2-D view as well as above and beneath the tissue to make sure that they have clear margins. "It drastically reduces the chances of the surgeon or radiologist having an error in margin measurements," said Butani.
The technology also has a zero warm up time and auto-calibration tools, which speed up the acquisition time. The speed and high-resolution of the image slices allow for quicker surgeries that require less anesthesia, which lowers the patient's risk of infection.
Kubtec first started talking about this new technology at the American Society of Breast Surgeons conference and also at the American College of Radiography conference. Butani said that the surgeons and radiologists at those conferences were "very keen" on trying out the unit when it becomes available.
"We have been contacting all of them and they are very interested in getting these units in," he said.
