Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software

Featuring a variety of artificial intelligence (AI) tools to enhance breast cancer detection with digital breast tomosynthesis (DBT), the SmartMammo Dx software has garnered expanded clearance from the Food and Drug Administration (FDA).¹

Previously cleared by the FDA in 2021 for use with Hologic mammography systems, SmartMammo Dx (DeepHealth/RadNet) can now be used with Senographe Pristina (GE HealthCare) mammography platforms.

DeepHealth said the SmartMammo Dx software assigns finding- and case-specific suspicion levels based on identification of soft tissue lesions and calcifications on DBT exams. The SmartMammo software has facilitated 23 percent higher detection of breast cancer in women with dense breasts and a 20 percent higher detection of breast cancer detection in African American women, according to DeepHealth.²

“This FDA clearance allows us to expand access to high-quality breast cancer screening to more patients,” said Kees Wesdorp, the president and CEO of DeepHealth. “By bringing SmartMammo’s improved cancer detection to GE HealthCare’s mammography systems, more providers can harness the power of AI to help redefine radiology workflows and address key challenges across the imaging value chain, to improve speed, clinical accuracy, operational efficiency, and elevate patient care.”

References

1. RadNet. Correction: RadNet’s DeepHealth subsidiary expands FDA clearance for SmartMammo™ solution. GlobeNewswire. Available at: https://www.globenewswire.com/news-release/2024/11/29/2989189/0/en/CORRECTION-RadNet-s-DeepHealth-Subsidiary-Expands-FDA-Clearance-for-SmartMammo-Solution.html . Published November 29, 2024. Accessed November 29, 2024.

2. DeepHealth. SmartMammo. Available at: https://deephealth.com/population-health/smart-mammo/ . Accessed November 29, 2024.