CHICAGO — In an industry first, GE Healthcare revealed Serena Bright™, its contrast-enhanced mammography solution for biopsy.
The company introduced the product during this year's Radiological Society of North America annual meeting.
The goal, said company representatives, is to add another biopsy option for women who have lesions not identified with mammography or ultrasound. Traditionally, contrast-enhanced biopsy has been performed with the more time-consuming, complex, expensive breast MR. In contrast, Serena Bright offers patients a biopsy in the same room, with the same mammography equipment, and with the same staff as they experience with their screening or diagnostic mammogram.
To identify malignant lesions previously not identified with mammography or ultrasound, Serena Bright uses GE Healthcare’s SenoBright™ HD Contrast Enhanced Spectral Mammography. It pinpoints unusual blood flow areas, helping to localize lesions requiring biopsy. In doing so, the tool can improve a radiologist’s diagnostic confidence and accelerate patient care, representatives said.
Like GE Healthcare’s Senographe Pristina™ system, Serena Bright offers patients the same comfort features, such as rounded edges. In addition, a robotic arm — which operates out of the patient’s field-of-view — automatically positions the needle for the biopsy.
U.S. Food & Drug Administration 510(k) clearance is pending with U.S. availability expected in 2020. To date, Serena Bright has been used in clinics in France and Spain with more than 20 cases completed. Additionally, GE Healthcare is currently partnering with the American College of Radiology to enroll women in a clinical trial that will compare contrast-enhanced mammography biopsy to other biopsy solutions. The trial will also begin in 2020.