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.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.