FDA approves marketing of AI-powered cardiac ultrasound software
The U.S. Food and Drug Administration (FDA) announced that it authorized marketing of software to help medical professionals acquire cardiac ultrasound images. The approved software, called Caption Guidance, is an accessory to diagnostic ultrasound systems and utilises artificial intelligence (AI) to assist the user capture images of a patient’s heart. These images are used in the diagnosis of various cardiac conditions of adult patients. The FDA representative said the marketing authorization is groundbreaking because it enables medical practitioners who may not be experts in ultrasonography to access safe and effective a diagnostics tool that demonstrates the capability of AI and machine learning.