- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
Biopsys resolves FDA labeling issue
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about
Mammography biopsy developer Biopsys of Irvine, CA, announcedlast week that the Food and Drug Administration has accepted itsplan to resolve the agency's concerns about labeling of the company'sMammotome biopsy device. The FDA was concerned about marketingmaterials for Mammotome that suggested that the device could beused for therapeutic applications, such as complete excision ofsuspicious breast lesions (SCAN 2/19/97).
As part of the resolution, Biopsys on Feb. 12 submitted a new510(k) application for Mammotome indicating that the product isspecifically intended for breast biopsy for diagnostic purposes.Biopsys will be able to continue selling Mammotome while the FDAreviews the new 510(k).
Four Strategies to Address the Tipping Point in Radiology
January 17th 2025In order to flip the script on the impact of the radiology workforce shortage, radiology groups and practices need to make sound investments in technologies and leverage partnerships to mitigate gaps in coverage and maximize workflow efficiencies.
Can Generative AI Facilitate Simulated Contrast Enhancement for Prostate MRI?
January 14th 2025Deep learning synthesis of contrast-enhanced MRI from non-contrast prostate MRI sequences provided an average multiscale structural similarity index of 70 percent with actual contrast-enhanced prostate MRI in external validation testing from newly published research.
Can MRI-Based AI Enhance Risk Stratification in Prostate Cancer?
January 13th 2025Employing baseline MRI and clinical data, an emerging deep learning model was 32 percent more likely to predict the progression of low-risk prostate cancer (PCa) to clinically significant prostate cancer (csPCa), according to new research.
