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Du Pont's Neurolite is `approvable'
Du Pont Merck Pharmaceuticalsis poised to become the second company with a brain SPECT agenton the U.S. market. The Food and Drug Administration has sentDu Pont an "approvable" letter for Neurolite, its technetium-taggedbrain imaging agent.
Du Pont Merck Pharmaceuticalsis poised to become the second company with a brain SPECT agenton the U.S. market. The Food and Drug Administration has sentDu Pont an "approvable" letter for Neurolite, its technetium-taggedbrain imaging agent.
Neurolite is indicated for brain perfusion studies in strokepatients. An FDA advisory committee recommended Neurolite forapproval last year (SCAN 6/30/93). Final FDA approval will begiven upon mutual agreement of labeling and phase-four studies,according to the company. Neurolite has regulatory approval inJapan and several European countries.
Neurolite's arrival would double the number of commerciallyavailable brain SPECT agents in the U.S. Amersham's technetium-labeledCeretec is currently the only brain SPECT agent being activelymarketed.
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
