FDA clearance for DeepHealth breast ultrasound tool
DeepHealth, a wholly owned RadNet subsidiary, won FDA 510(k) clearance for an AI-powered breast ultrasound product.
The product targets lesion detection, characterization, and reporting automation; accuracy is above 98%, cancer-detection sensitivity is up 8%, and interpretation time is cut 37%.
Commercial US rollout begins immediately; customers can seek reimbursement under an existing Category III CPT code.
Deployment is planned across RadNet centers by year-end, and more than 700,000 annual breast ultrasound exams may qualify for reimbursement.
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