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DeepHealth Receives FDA Clearance for AI-Powered Breast Ultrasound

$RDNTPress releaseJul 30, 2026, 4:15 PM ETRead the release

DeepHealth, a wholly owned subsidiary of RadNet, received FDA 510(k) clearance for its AI-powered Breast Ultrasound solution, automating lesion detection, characterization, and reporting. Clinical validation demonstrated over 98% accuracy in lesion localization and an 8% improvement in sensitivity, while reducing radiologist interpretation time by 37%.

Key figures

Annual eligible studies
700000
Sensitivity improvement
8%
Lesion localization accuracy
98%
Interpretation time reduction
37%

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