FDA-cleared portable automated 3D breast ultrasound scanner that images the full breast volume in 2 minutes without requiring a trained ultrasound operator.
ATUSA is iSono Health's FDA 510(k)-cleared automated 3D breast ultrasound scanner designed for use at physician offices and women's health clinics without requiring a trained ultrasound technologist. The device captures a full 3D breast scan in approximately 2 minutes per breast using a wearable accessory, making it 10-15x faster than manual probing. Images are stored locally and backed up to HIPAA-compliant cloud storage, viewable through a secure web app with 3D visualization in radial, coronal, sagittal, and transverse views. The system includes AI decision support tools for lesion localization and supports personalized longitudinal monitoring for high-risk individuals. ATUSA is a product of iSono Health.
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