FDA clears GE HealthCare's automated breast ultrasound platform
The U.S. Food and Drug Administration recently cleared a new automated breast ultrasound (ABUS) platform from GE HealthCare.
The Chicago-based manufacturer announced the launch of its Invenia ABUS Prime and ABUS StreamVue enterprise viewing platform on Monday, the latter of which received FDA clearance and CE Marking in late July. The technologies were designed to improve supplemental screening for women with dense breasts.
GE's newly cleared solution is intended to help breast imaging programs standardize breast ultrasound exams, enable remote interpretation and simplify deployment across imaging networks. The company hopes the platform can help address growing demand for supplemental screening, as dense breast tissue both increases breast cancer risk and makes cancers more difficult to identify on mammography.
Invenia ABUS Prime includes several AI-enabled features designed to improve image quality and workflow, among them, an AI-assisted image review to help radiologists spot difficult-to-detect lesions with 93% sensitivity and reduce interpretation times by up to 33%. It also comes equipped with a Fast Scan tool that reduces acquisition times by up to 40% and a redesigned transducer aimed at improving patient comfort.
The newly cleared ABUS StreamVue is a browser-based, zero-footprint enterprise viewer that enables radiologists to review ultrasound exams remotely without dedicated workstation software. The platform, which was developed in collaboration with Candelis, is designed to simplify installation and maintenance while supporting standardized image review across multiple sites.
“ABUS StreamVue extends the value of our ABUS platform with a flexible reading experience for enterprise imaging environments,” Russ Behler, global product director for LOGIQ Ultrasound at GE HealthCare, said in an announcement Aug. 3. “This solution supports remote review, more standardized presentation, and simpler deployment across care settings.”
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.