- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
Approval of Siemens digital mammo nears
The FDA has issued an approvable letter for Siemens Mammomat NovationDR, a full-field digital mammography system. The agency found that the device is approvable, pending successful FDA inspection of Siemens' manufacturing facility in Erlangen, Germany,
The FDA has issued an approvable letter for Siemens Mammomat NovationDR, a full-field digital mammography system. The agency found that the device is approvable, pending successful FDA inspection of Siemens' manufacturing facility in Erlangen, Germany, and agreement on the labeling to go with the system. The NovationDR, built around an amorphous selenium detector, supports digital screening, diagnosis, and stereotactic biopsy.
FDA Clears Updated AI Platform for Digital Breast Tomosynthesis
November 12th 2024Employing advanced deep learning convolutional neural networks, ProFound Detection Version 4.0 reportedly offers a 50 percent improvement in detecting cancer in dense breasts in comparison to the previous version of the software.
Is the Kaiser Score More Effective than BI-RADS for Assessing Contrast-Enhanced Mammography and MRI?
October 14th 2024For women with breast-enhanced masses, Kaiser scoring (KS) demonstrated a 20 percent higher AUC than BI-RADS classification for contrast-enhanced mammography (CEM) and was comparable to KS for breast MRI.
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.
