- AI
- Molecular Imaging
- CT
- X-Ray
- Ultrasound
- MRI
- Facility Management
- Mammography
FDA gives Combidex OK for lymph node imaging
Advanced Magnetics is halfway to an NDA approval for its MR contrast agent, Combidex. The FDA this month sent the company a letter saying that although it found Combidex approvable for its principal indication, as a lymph node imaging agent, it could not
Advanced Magnetics is halfway to an NDA approval for its MR contrast agent, Combidex. The FDA this month sent the company a letter saying that although it found Combidex approvable for its principal indication, as a lymph node imaging agent, it could not approve the agent for its secondary indication, imaging of the liver and spleen.
Jerome Goldstein, chairman and CEO of Advanced Magnetics, said his company should be able to meet the FDAs remaining conditions. Goldstein added that Combidex is the first lymph-node-specific MR contrast agent to be filed with the FDA.
The company has incurred financial losses waiting for approval to market this product. Advanced Magnetics showed a net loss this year of $1 million for the quarter ending March 31, compared to a net loss of $793,858 for the same period last year.
Advanced Magnetics develops MR contrast agents for the diagnosis of cancer and other diseases. The firm submitted its new drug application for Combidex to the FDA in December 1999. Advanced Magnetics European marketing partner, Guerbet, also submitted the European equivalent of an NDA to the European Medicines Evaluations Agency. Combidex is the third product Advanced Magnetics has developed (SCAN 5/24/00).
Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI
December 19th 2024In a new study involving nearly 600 biopsy-naïve men, researchers found that only 4 percent of those with negative prostate MRI had clinically significant prostate cancer after three years of active monitoring.
Study Examines Impact of Deep Learning on Fast MRI Protocols for Knee Pain
December 17th 2024Ten-minute and five-minute knee MRI exams with compressed sequences facilitated by deep learning offered nearly equivalent sensitivity and specificity as an 18-minute conventional MRI knee exam, according to research presented recently at the RSNA conference.
Can Radiomics Bolster Low-Dose CT Prognostic Assessment for High-Risk Lung Adenocarcinoma?
December 16th 2024A CT-based radiomic model offered over 10 percent higher specificity and positive predictive value for high-risk lung adenocarcinoma in comparison to a radiographic model, according to external validation testing in a recent study.
