FDA Greenlights Increased Use of Artificial Intelligence in Healthcare Imaging

The Food and Drug Administration (FDA) in the US is accelerating the pace at which the use of artificial intelligence in healthcare imaging are approved. Clearance was granted to Ultromics, based in the United Kingdom, for an image analysis system that automates cardiac analysis to aid in the early detection of cardiovascular disease. Ultromics’ system (EchoGo Core) applies AI to echocardiography, aiming to automate the analysis and quantification of ultrasound-based heart scans. The FDA also has approved technology from Hologic, a Marlborough, Mass.-based company that uses an AI-powered algorithm that the company contends can reduce mammography read times without compromising image quality, sensitivity or accuracy. Hologic’s system uses a three-dimensional imaging approach, called tomosynthesis, which provides better results than two-dimensional imaging approaches, particularly for women with dense breasts. Hologic’s new core AI platform aims to provide advanced cancer detection, operational efficiency and clinical decision support across the breast cancer care system.