FDA Clears GE’s Automated Breast Ultrasound Platform for Dense Breasts

FDA clears GE HealthCare’s Invenia ABUS Prime and StreamVue for automated breast ultrasound supplemental screening in dense breasts. Company says AI-assisted review has 93% sensitivity, 33% faster interpretation, and 40% faster acquisition.

• StreamVue is a zero-footprint browser-based viewer enabling remote interpretation across enterprise networks.
• The platform also features a redesigned transducer for patient comfort and a Fast Scan tool reducing acquisition time.
• Both FDA clearance and CE marking were received in late July.

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