with the FDA about using diverse datasets, such as AI breast imaging detection provider iCAD. FCRm is the world’s most widely used digital mammography technology with shipment of more than 4,400 systems worldwide. PMA No. Of the 161 products that STAT found the FDA approved. Since Fujifilm received FDA approval for FCRm in July 2006, the company has enjoyed record sales in the US market, enabling the conversion to digital of nearly 500 mammography exam rooms. iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval. “Additionally, seamless integration of iCAD’s product with our PACS system will improve the efficiency of our reading and our overall digital workflow. iCAD's solutions aid in the early detection of the most prevalent cancers including breast and prostate, and in the future colon and lung cancer. Elizabeth’s Medical Center in Boston, Massachusetts. Since receiving FDA approval for the Company's first breast cancer detection product in 2002, more than 3,500 iCAD systems have been placed in healthcare practices worldwide. ICAD’s SecondLook Digital system coupled with the Fuji CR Mammography system will improve our ability to detect potentially malignant calcifications and masses and we expect that it will increase our overall standard of care,” said Jeffrey Mendel, M.D., Chairman of Radiology at Caritas St.
SecondLook Digital for FCRm is the first CAD product approved and available in the U.S. Food and Drug Administration for sale with Fujifilm Computed Radiography for Mammography (FCRm) systems. ICAD’s SecondLook® Digital Computer-Aided Detection system for mammography received approval from the U.S.