The FDA has cleared for marketing three computer-assisted detection technologies developed by iCAD: iDM, which works with Fischer Imaging's SenoScan full-field digital mammography system; iAD, a full-featured stand-alone unit, and iQ, a low-cost
The FDA has cleared for marketing three computer-assisted detection technologies developed by iCAD: iDM, which works with Fischer Imaging's SenoScan full-field digital mammography system; iAD, a full-featured stand-alone unit, and iQ, a low-cost stand-alone unit. Following the FDA approvals, iCAD and Fischer announced an expanded development and distribution agreement that includes the new iAD product, which reads digitized mammography films. iCAD, located in Nashua, NH, plans to market the device to women's health centers and breast clinics that perform fewer than 20 mammography procedures a day.
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.