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iSono Health has developed and commercialized the world's first AI-driven, automated, portable, and wearable 3D breast ultrasound system—ATUSA™, designed for fast, repeatable, operator-independent breast imaging at the point of care. The system is FDA-cleared, intended for use alongside (not as a replacement for) mammography, particularly relevant for patients with dense breast tissue[1][3][6]. ATUSA is not a therapeutic device, but an imaging platform that captures the entire breast volume in about 2 minutes per breast, with automated analysis and cloud-based image storage. It enables longitudinal breast monitoring, especially for high-risk individuals, and is being evaluated for further integration of AI-based lesion detection and classification[1][3][4].
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