- 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).
Computed Tomography Study Assesses Model for Predicting Recurrence of Non-Small Cell Lung Cancer
January 31st 2025A predictive model for non-small cell lung cancer (NSCLC) recurrence, based on clinical parameters and CT findings, demonstrated an 85.2 percent AUC and 83.3 percent sensitivity rate, according to external validation testing in a new study.
