Iodinated Contrast Media Alternative: FDA OKs Bayer Importing Foreign-Labeled Iopromide
The Food and Drug Administration (FDA) has given the green light to Bayer to import foreign-labeled iopromide (Ultravist) to help alleviate ongoing supply challenges with iodinated contrast media in the United States.
In light of continued supply issues with iodinated contrast media stemming from a temporary COVID-19-related shutdown of a GE Healthcare manufacturing plant in Shanghai earlier this year, the Food and Drug Adminstration (FDA) is allowing Bayer to import and distribute foreign-labeled iopromide (Ultravist) in the United States.
Bayer emphasized that Ultravist is indicated for intra-arterial and intravenous administration. The modality is contraindicated for intrathecal administration, according to Bayer.
The company added that clinicians should be aware of differences between the package inserts for the foreign-labeled iopromide and the U.S. version, and defer to the U.S. prescribing information for iopromide.
For additional questions about the use of iopromide, one may contact Bayer Healthcare Pharmaceuticals at (888) 842-2937.
(Editor’s note: For related content, see “Iodinated Contrast Media Shortage: Practical Solutions and Applications in Radiology,” “Lessons Learned from the Iodinated Contrast Media Shortage: A Neuroradiologist’s Perspective,” “Emerging Strategies for Managing the Acute Shortage of Iodinated Contrast Media” and “Iodinated Contrast Media: 15 Recommendations for Addressing the Shortage.”)
Photon-Counting Computed Tomography: Eleven Takeaways from a New Literature Review
May 27th 2025In a review of 155 studies, researchers examined the capabilities of photon-counting computed tomography (PCCT) for enhanced accuracy, tissue characterization, artifact reduction and reduced radiation dosing across thoracic, abdominal, and cardiothoracic imaging applications.
Can AI Predict Future Lung Cancer Risk from a Single CT Scan?
May 19th 2025In never-smokers, deep learning assessment of single baseline low-dose computed tomography (CT) scans demonstrated a 79 percent AUC for predicting lung cancer up to six years later, according to new research presented today at the American Thoracic Society (ATS) 2025 International Conference.
Can Emerging AI Software Offer Detection of CAD on CCTA on Par with Radiologists?
May 14th 2025In a study involving over 1,000 patients who had coronary computed tomography angiography (CCTA) exams, AI software demonstrated a 90 percent AUC for assessments of cases > CAD-RADS 3 and 4A and had a 98 percent NPV for obstructive coronary artery disease.
