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SenoScan clears FDA
Customers shopping for full-field digital mammography systems have another product to consider. The FDA has cleared Fischer Imaging’s SenoScan for sale in the U.S. In making the announcement Sept. 25, Fischer executives predicted that a large
Customers shopping for full-field digital mammography systems have another product to consider. The FDA has cleared Fischer Imaging’s SenoScan for sale in the U.S. In making the announcement Sept. 25, Fischer executives predicted that a large portion of the currently installed 30,000 screen-film mammography systems would eventually be replaced by digital systems, with the conversion rate reaching as high as 1500 systems per year by 2007. So far, only Fischer and GE Medical Systems have been cleared to sell such products. Prior to the FDA decision, Fischer announced the sale of five SenoScans to research institutions participating in a $26 million study sponsored by the National Cancer Institute to determine the accuracy of digital mammography. SenoScan, which is built around a slot scanning digital detector, can support computer-aided detection software, tomosynthesis involving 3-D imaging, and contrast subtraction mammography.
FDA Clears Updated AI Platform for Digital Breast Tomosynthesis
November 12th 2024Employing advanced deep learning convolutional neural networks, ProFound Detection Version 4.0 reportedly offers a 50 percent improvement in detecting cancer in dense breasts in comparison to the previous version of the software.
Is the Kaiser Score More Effective than BI-RADS for Assessing Contrast-Enhanced Mammography and MRI?
October 14th 2024For women with breast-enhanced masses, Kaiser scoring (KS) demonstrated a 20 percent higher AUC than BI-RADS classification for contrast-enhanced mammography (CEM) and was comparable to KS for breast MRI.
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.
