Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.
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.
Assigning finding- and case-specific suspicion levels for breast cancer based on identification of soft tissue lesions and calcifications on digital breast tomosynthesis (DBT), the SmartMammo Dx software recently garnered expanded FDA clearance for use with the Senographe Pristina (GE HealthCare) mammography platforms. (Image courtesy of DeepHealth.)
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.
Could AI-Powered Abbreviated MRI Reinvent Detection for Structural Abnormalities of the Knee?
April 24th 2025Employing deep learning image reconstruction, parallel imaging and multi-slice acceleration in a sub-five-minute 3T knee MRI, researchers noted 100 percent sensitivity and 99 percent specificity for anterior cruciate ligament (ACL) tears.
Meta-Analysis Shows Merits of AI with CTA Detection of Coronary Artery Stenosis and Calcified Plaque
April 16th 2025Artificial intelligence demonstrated higher AUC, sensitivity, and specificity than radiologists for detecting coronary artery stenosis > 50 percent on computed tomography angiography (CTA), according to a new 17-study meta-analysis.
