"The decrease in cancer recall rate in Reader Study 1 raises concerns, but the results for Reader Study 2 suggest that with better training the recall rate could decrease without the loss of cancers," the agency said.
Also among the agency's worries is the level of radiation per scan. The FDA's Mammography Quality Standards Act requires the radiation dose to the breast not to exceed, for a typical breast, around 3 mGy for a single craniocaudal view. In phantom studies submitted to the FDA for the Hologic device, the agency said total dose for 2-D plus 3-D, totaling four views, is 5 mGy, and for three views, 3.5 mGy.
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However, the FDA said the "glandular dose to a phantom simulating a standard breast for 2D plus 3D would be less than twice the MQSA limit for single CC view."
A spokesman from Hologic told DOTmed News that dose for 2-D and 3-D combined falls below the FDA regulatory limit for a single 2-D exposure, and that the additional effective dose from the 3-D scan is about the same as two months of annual natural background radiation.
The response from the market has been mixed. Hologic's stock fell 3.9 percent to close at $15.42 on Nasdaq. But some analysts are upbeat about the device's prospects.
"[We] believe that risk/reward heading into the [Center for Devices and Radiological Health] panel meeting is favorable," Jefferies, an investment bank, said according to Benzinga.
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