Cedara gets FDA clearance for mammography reading workstation
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.
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.