GE Healthcare and Bracco have both received notices of violation from the U.S. Food and Drug Administration (FDA) for marketing claims related to their Visipaque and Isovue x-ray contrast agents.
In its letter to GE of Chalfont St. Giles, U.K., the FDA said that the Web site for Visipaque was misleading because it presents unsubstantiated comparative claims and omits and minimizes the risks associated with the agent. The FDA also informed Bracco that its Web site for Isovue contains false and unsubstantiated claims, and that it omits and minimizes the risks associated with the agent's use.
A GE spokesperson told AuntMinnie.com that the company is cooperating with the FDA, and that it is currently reviewing and updating, when appropriate, materials related to Visipaque.
A spokesperson for Milan, Italy-based Bracco told AuntMinnie.com that while the company respectfully disagrees with the FDA's comments related to claims regarding the IMPACT study, on which its claims were based, the firm intends to cooperate fully. The company said it has already responded to the FDA and has removed the material to which the FDA objected.
Related Reading
GE Healthcare revenues slip in 2009, January 22, 2010
GE, Intel expand pact to U.K., January 5, 2010
GE licenses molecular radiotracers, December 29, 2009
Judge gives Bracco partial victory in patent case, August 28, 2009
Bracco debuts new CardioGen pump at SNM show, June 15, 2009
Mallinckrodt sues Bracco, April 9, 2009
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![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
