- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
Biofield submits PMA for breast device
The Food and Drug Administration has agreed to provide expeditedreview of an Atlanta start-up company's premarket approval (PMA)application for a device designed to identify malignant breastlesions without surgical biopsy. Biofield's Alexa 1000
The Food and Drug Administration has agreed to provide expeditedreview of an Atlanta start-up company's premarket approval (PMA)application for a device designed to identify malignant breastlesions without surgical biopsy. Biofield's Alexa 1000 devicecould compete with technologies such as ultrasound in providingnoninvasive breast lesion characterization without the use ofx-rays.
Alexa 1000 employs single-use sensors and a measurement deviceto detect and analyze changes in cellular electrical charge distributionsassociated with the development of epithelial cancers, such asbreast cancer. A multicenter clinical study of over 1000 womenin the U.S. found that the system was about 95% accurate in identifyingmalignant breast lesions.
Biofield's stock leaped 59% to $14.12 a share on the news thatAlexa 1000's PMA was accepted by the FDA, and was trading at about$14.75 this week.
Can AI Enhance CT Detection of Incidental Extrapulmonary Abnormalities and Prediction of Mortality?
September 18th 2024Emphasizing multi-structure segmentation and feature extraction from chest CT scans, an emerging AI model demonstrated an approximately 70 percent AUC for predicting significant incidental extrapulmonary findings as well as two-year and 10-year all-cause mortality.
Comparing Digital Breast Tomosynthesis to Digital Mammography: What a Long-Term Study Reveals
September 17th 2024In a study involving over 272,000 breast cancer screening exams, digital breast tomosynthesis (DBT) had a higher breast cancer detection rate and a lower rate of advanced cancer presentation at the time of diagnosis in comparison to digital mammography.
Can Radiomics Enhance Differentiation of Intracranial Aneurysms on Computed Tomography Angiography?
September 17th 2024Radiomics models offered a pooled AUC of 86 percent for differentiating between ruptured and unruptured intracranial aneurysms, according to a recently published meta-analysis.
