Cedara Software Corp. announced this week the FDA 510(k) clearance of its Cedara I-ReadMammo, a new mammography reading workstation for diagnosis and screening.
FDA clearance now permits Cedara to sell I-ReadMammo in the United States, which currently is the largest market for mammography and one of the fastest growing digital mammography markets in the world.
The I-ReadMammo allows radiologists to read images from mammography systems from multiple vendor FFDM (full-field digital mammography) products. In addition to x-ray mammography, the multi-modality system handles ultrasound and MRI images. Cedara also notes that centers transitioning to digital imaging can utilize the workstation since it integrates easily with a film digitizing application.
Tests of the Cedara I-ReadMammo workstation have been performed in cooperation with a number of mammography centers around the world, including the Elizabeth Wende Breast Clinic in New York, the Lund University Hospital in Sweden, and Burlington Ultrasound and Radiology Clinic in Canada.