Goto

Collaborating Authors

 fda clear world


FDA Clears World's First AI-Driven Portable 3D Breast Ultrasound Scanner

#artificialintelligence

This week iSono Health announced FDA clearance of the company's ATUSA System for breast imaging. This is world's first AI-driven portable and automated 3D breast ultrasound scanner. In just 2 minutes, the ATUSA system automatically scans the entire breast volume, independent of operator expertise, and offers 3D visualization of the breast tissue. The ATUSA system is designed from the ground up to seamlessly integrate with advanced machine learning models that will give physicians a comprehensive set of tools for decision making and patient management. This is the first of several intended FDA submissions for the company.