ATUSA System

The world's first AI-driven portable and automated 3D breast ultrasound scanner

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Description

The ATUSA System, developed by iSono Health, is a portable device designed for automated 3D breast ultrasound imaging. It enables comprehensive scanning of the entire breast volume quickly, typically within two minutes per breast, without needing a specialized ultrasound operator. This facilitates repeatable, standardized imaging directly at the point of care, such as physicians' offices and women's health clinics, making breast imaging more accessible and comfortable for patients.

The system incorporates a wearable accessory and an intuitive software suite that offers real-time 2D visualization during acquisition and advanced 3D visualization tools (including radial, coronal, sagittal, and transverse views) for lesion localization and analysis. While described as AI-driven, potential AI features supporting diagnosis or analysis are currently investigational and not cleared for clinical use. The platform supports personalized longitudinal monitoring for high-risk individuals and enables remote image access via a secure cloud connection, aiding in patient management and tracking changes over time. The ATUSA system has received FDA 510(k) clearance for its scanning and visualization capabilities.

Key Features

Automated 3D Ultrasound Scans: Captures the entire breast volume automatically.
Operator-agnostic Acquisition: Allows use by physicians, nurses, or medical assistants without specialized ultrasound training.
Fast Scanning: Completes a whole breast scan in approximately 2 minutes per breast.
Consistent & Standardized Imaging: Ensures reproducible image acquisition across patients.
Advanced 3D Visualization: Provides interactive whole breast visualization and lesion localization.
Real-time 2D Image Visualization: Displays images during the scanning process.
Portable Design with Wearable Accessory: Enhances patient comfort and ease of use.
ATUSA Software Suite: Offers tools for image review, measurement, and management.
Remote Monitoring Capability: Enables cloud-based remote access for tracking and care.
Personalized Longitudinal Monitoring: Facilitates regular monitoring for high-risk individuals.

Use Cases

Point-of-care breast ultrasound imaging.
Frequent screening and monitoring for high-risk women.
Longitudinal tracking of breast tissue changes.
Supplementing clinical breast exams in physician offices.
Improving patient access and comfort for breast imaging.
Remote consultation and patient management via cloud access.

Frequently Asked Questions

Who is the ATUSA System designed for?

Initially, it's aimed at physicians' offices and women’s health clinics. It can be operated by physicians, nurses, and medical assistants for image acquisition.

What are the components of the ATUSA system?

It includes a 3D ultrasound scanner, a wearable accessory, a Windows application for image display and review, and a secure web application for remote viewing with advanced 3D visualization.

What kind of training is required to use ATUSA?

Image acquisition does not require a radiologist or ultrasound technologist; instructional videos and an initial training session are provided. However, image interpretation requires a physician trained in breast ultrasound.

How does the ATUSA scanner connect, and is internet required?

It connects via USB to a tablet or laptop and does not require internet for operation. Images are saved locally and automatically backed up to a secure cloud when internet is available.

Where can I try or purchase the ATUSA system?

Healthcare professionals can register for a free demo or inquire about the pilot program. The system is currently available for investigational use only and is not yet for sale.