Outpatient diagnostic imaging solutions company DeepHealth, Inc., a subsidiary of RadNet, Inc. (NASDAQ:RDNT), announced on Friday that it has received expanded FDA 510(k) clearance for its SmartMammo Dx AI software, now compatible with GE HealthCare's Senographe Pristina mammography systems.

Initially cleared in May 2012 for HOLOGIC mammography systems, SmartMammo Dx has been proven effective in patients with unilateral breasts and implants. This expanded clearance broadens DeepHealth's mission to improve breast cancer screening by increasing system compatibility.

SmartMammo Dx, a core component of the SmartMammo1 solution, enhances radiologists' ability to interpret digital breast tomosynthesis (DBT) mammograms with greater accuracy. It identifies suspicious lesions and calcifications while providing detailed case-specific suspicion levels. DeepHealth's technologies have supported millions of exams in the past two years through the Enhanced Breast Cancer Detection (EBCD) program at RadNet.

This expanded clearance is expected to drive broader adoption of AI-powered breast cancer screening, benefiting both RadNet and external providers. It also highlights the collaboration between DeepHealth and GE HealthCare to advance patient-centric, scalable imaging solutions.