- 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.
Multicenter Study Identifies Key Factors Associated with Mammogram-Occult Ipsilateral Breast Cancer
October 9th 2024A symptomatic first breast cancer diagnosis, prevailing breast density at a second breast cancer diagnosis and trabecular thickening on surveillance mammography were linked to mammogram-occult ipsilateral breast cancer, according to new research.
AI Mammography Platform Shows Promising Results for Detecting Subclinical Breast Cancer
October 3rd 2024Mean artificial intelligence (AI) scoring for breasts developing cancer was double that of contralateral breasts at initial biennial screening and was 16 times higher at the third biennial screening, according to a study involving over 116,000 women with no prior history of breast cancer.
