- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
Selenia nears FDA approval
The FDA issued Hologic an approvable letter in mid-July for its Lorad Selenia digital mammography system. The full-field product is based on an amorphous selenium detector plate developed by Direct Radiography, which Hologic purchased three years ago.
The FDA issued Hologic an approvable letter in mid-July for its Lorad Selenia digital mammography system. The full-field product is based on an amorphous selenium detector plate developed by Direct Radiography, which Hologic purchased three years ago. The letter, issued in response to a premarket approval application, is the last step before the product is formally accepted by the FDA for sale in the U.S. The letter indicates that the agency will likely allow marketing of Selenia for soft- as well as hard-copy reading. Hologic already has an FDA-approved full-field system, the Lorad Digital Breast Imager. This product, which the FDA approved in March, depends on a charge-coupled detector. Selenia, which uses a more sophisticated direct capture detector, will make this older system obsolete, according to the company.
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.
