- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
Nycomed receives warning from FDA
Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL,
Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL, radiopharmaceutical manufacturing facility. It cited Nycomed Amersham for neglecting to maintain FDA standards in the clean room in which NeoScan, indium DTPA, and thallous chloride are manufactured.
In addition, the letter raised concerns about Nycomed Amersham's ability to confirm the sterility of the agent technetium Tc 99m following reprocessing procedures, as well as the company's lack of standard protocols for cleaning and maintaining manufacturing equipment. The company is working closely to resolve the FDA's concerns, and there has not been any interruption of product deliveries, according to Carol Perlman, Nycomed spokesperson.
MRI-Based AI Radiomics Model Offers 'Robust' Prediction of Perineural Invasion in Prostate Cancer
July 26th 2024A model that combines MRI-based deep learning radiomics and clinical factors demonstrated an 84.8 percent ROC AUC and a 92.6 percent precision-recall AUC for predicting perineural invasion in prostate cancer cases.
Breast MRI Study Examines Common Factors with False Negatives and False Positives
July 24th 2024The absence of ipsilateral breast hypervascularity is three times more likely to be associated with false-negative findings on breast MRI and non-mass enhancement lesions have a 4.5-fold likelihood of being linked to false-positive results, according to new research.
Can Polyenergetic Reconstruction Help Resolve Streak Artifacts in Photon Counting CT?
July 22nd 2024New research looking at photon-counting computed tomography (PCCT) demonstrated significantly reduced variation and tracheal air density attenuation with polyenergetic reconstruction in contrast to monoenergetic reconstruction on chest CT.
