GE HealthCare launches two breast imaging products for dense breasts
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GE HealthCare (NASDAQ: GEHC) announced the launch of Invenia ABUS Prime, an automated breast ultrasound system, and ABUS StreamVue, a browser-based exam review solution, expanding its breast imaging portfolio for supplemental screening of women with dense breasts.
Invenia ABUS Prime has received U.S. FDA premarket approval and CE Marking. The system includes AI-enabled tools for scan quality assessment and auto nipple detection, a fast scan feature that the company says increases scan speed by up to 40% compared to the prior Invenia ABUS 2.0 model, and an AI-assisted reading tool that GE HealthCare says has demonstrated a 33% reduction in reading time and up to 93% sensitivity for lesion detection, based on published research.
ABUS StreamVue, powered by Candelis, Inc., received U.S. FDA 510(k) clearance and CE Marking. The zero-footprint, browser-based solution is designed to allow remote review of ABUS exams across enterprise imaging networks.
One of the first U.S. installations of Invenia ABUS Prime has taken place at BeSound, a breast imaging center in Los Angeles. BeSound founder and CEO Bailey Renger said the system is intended to expand access to supplemental breast screening.
According to studies cited in the press release, approximately 40% of women in the U.S. and Europe have dense breasts, which can make cancers harder to detect on mammography. Research has indicated mammography may miss one-third of cancers in dense breasts.
GE HealthCare noted that availability of both products is subject to local regulatory approvals and may vary by country.
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