DeepHealth, Inc., a subsidiary of RadNet, Inc. (NASDAQ: RDNT), has received expanded FDA 510(k) clearance for its groundbreaking mammography software, SmartMammo™. The enhanced clearance, announced recently, allows SmartMammo Dx, an AI algorithm, to be compatible with GE HealthCare’s Senographe Pristina™ mammography systems. This move builds on the original 2012 FDA clearance, where SmartMammo Dx was approved for use with HOLOGIC mammography systems. The newly expanded clearance aims to broaden the impact of this AI-driven diagnostic technology, helping to improve and expand breast cancer screening programs by increasing compatibility with various mammography systems.
Kees Wesdorp, President and CEO of RadNet’s Digital Health segment, emphasized the importance of this new development, stating, “This FDA clearance allows us to expand access to high-quality breast cancer screening to more patients.” By making SmartMammo’s advanced cancer detection capabilities available to GE HealthCare’s mammography systems, the technology will reach a wider group of providers. This, in turn, is expected to drive significant improvements in radiology workflows, boosting clinical accuracy and operational efficiency while enhancing patient care.
SmartMammo Dx is a critical part of DeepHealth’s comprehensive SmartMammo™ solution. The software utilizes advanced AI tools to assist radiologists in interpreting digital breast tomosynthesis (DBT) mammograms with higher precision. SmartMammo Dx identifies suspicious soft tissue lesions and calcifications and assigns specific levels of suspicion based on the findings. This detailed approach increases diagnostic accuracy and assists radiologists in making more informed decisions.
The AI-powered diagnostic technology has already demonstrated its value over the past two years through the Enhanced Breast Cancer Detection (EBCD) program at RadNet, where it has supported millions of mammography exams performed with HOLOGIC systems. The expanded FDA clearance for GE HealthCare’s Senographe Pristina mammography systems is expected to further accelerate the adoption of SmartMammo Dx, particularly in both RadNet’s own facilities and other imaging providers across the country. This expanded reach of the AI technology will ensure that more patients benefit from the advanced detection capabilities SmartMammo Dx offers.
The FDA clearance also highlights the ongoing partnership between DeepHealth and GE HealthCare, two organizations with a shared commitment to improving breast cancer detection. Together, they aim to set new standards in AI-powered imaging that can help radiologists deliver faster and more accurate care to patients. By integrating AI into breast cancer screening, the collaboration seeks to make mammography more effective and accessible for both patients and healthcare providers.
SmartMammo Dx is just one component of the broader SmartMammo™ solution. The solution includes SmartMammo Density, DeepHealth Viewer, and SmartMammo Assure, all designed to enhance the precision and efficiency of breast cancer screenings. DeepHealth Viewer, for instance, is manufactured by eRAD and distributed by DeepHealth, and all components work together to provide a comprehensive AI-powered solution for breast imaging.
RadNet, Inc. is the largest provider of outpatient diagnostic imaging services in the United States, with a network of 399 imaging centers across major markets such as California, New York, Florida, and Texas. As the leading provider of radiology services, RadNet also markets AI solutions under the DeepHealth brand. These solutions are designed to improve the efficiency and accuracy of diagnostic imaging, and they complement RadNet’s extensive network of imaging centers.
DeepHealth itself is focused on leveraging AI-powered health informatics to make breakthroughs in imaging. It is dedicated to improving clinical outcomes by enhancing operational efficiency and enabling earlier, more reliable disease detection. Through its AI-powered solutions, DeepHealth addresses a range of health concerns, including lung, prostate, brain, and breast cancers. At the core of DeepHealth’s portfolio is DeepHealth OS, a cloud-native operating system that unifies clinical and operational data and personalizes AI-driven workflows for radiologists.
The expanded FDA clearance for SmartMammo Dx marks a significant milestone for both RadNet and DeepHealth, as it extends the impact of AI-driven diagnostic technology to a broader network of healthcare providers. As AI continues to play an essential role in improving patient care, the expansion of this technology in breast cancer screening holds the potential to make early detection more accurate, efficient, and accessible for patients across the country.
