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BioWorld - Saturday, February 14, 2026
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Home » FDA greenlights Isono Health’s wearable breast ultrasound system
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FDA greenlights Isono Health’s wearable breast ultrasound system

May 3, 2022
By Annette Boyle
Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.
Medical technology Regulatory Diagnostics Artificial intelligence Imaging Digital health Wearable Cancer U.S. 510(k) FDA

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