Kodak CAD nears market
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.