The FDA has issued an approvable letter for a mammography CAD device developed by Kodak. Approvable letters usually precede final FDA consent for marketing, provided certain criteria are met. Kodak plans to offer the CAD technology as a stand-alone
The FDA has issued an approvable letter for a mammography CAD device developed by Kodak. Approvable letters usually precede final FDA consent for marketing, provided certain criteria are met. Kodak plans to offer the CAD technology as a stand-alone product and as a component of its digital capture and image-and-information management systems. According to the company, clinical trial results submitted to the FDA suggest that 39.4% of missed breast cancers would be detected 14.8 months earlier if Kodak's new technology were used.
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.