RadNet (RDNT), a diagnostic imaging and AI-driven health solutions, on Friday announced that its DeepHealth subsidiary has received expanded FDA 510(k) clearance for its SmartMammo AI algorithm.
This new clearance allows SmartMammo Dx to be used with GE HealthCare's Senographe Pristina mammography systems, significantly broadening its accessibility and capabilities for breast cancer screening.
SmartMammo Dx, initially cleared in 2021 for use with HOLOGIC systems, is now FDA-cleared to integrate with GE HealthCare's Pristina systems, bringing enhanced AI-driven breast cancer detection to a wider range of healthcare providers.
This advancement is expected to improve diagnostic accuracy by helping radiologists better identify suspicious soft tissue lesions and calcifications in mammograms, offering greater precision in detecting early-stage breast cancer.
RadNet's DeepHealth solutions have already been widely adopted across RadNet's network of imaging centers, and with this expanded clearance, the company expects to accelerate the adoption of its AI-powered SmartMammo solution at both RadNet and other providers.
RDNT closed Thursday's (Nov. 27, 2024) trading at $82.49, up 1.28 %. In premarket trading today, the stock is up by 1.81 % at $83.98
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