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Perflubron (INN/USAN, or perfluorooctyl bromide; brand name Imagent) is a contrast medium for magnetic resonance imaging, computer tomography and sonography. [1] It was approved for this use in the United States by the Food and Drug Administration in 1993. [2]
The FDA Modernization Act of 1997 was instituted to improve the regulatory process for medical products. Section 112 of the Act gives explicit authority to give expedited approval for drugs that treat serious conditions as long as it has shown to have an effect on a surrogate end-point that reasonably indicates a clinical benefit.
Magnetic resonance fingerprinting (MRF) is methodology in quantitative magnetic resonance imaging (MRI) characterized by a pseudo-randomized acquisition strategy. It involves creating unique signal patterns or 'fingerprints' for different materials or tissues after which a pattern recognition algorithm matches these fingerprints with a predefined dictionary of expected signal patterns.
Medical device maker Medtronic announced in a press release yesterday that it has won FDA regulatory approval for its Advisa DR MRI SureScan pacemaker. The Advisa is Medtronic's second MR ...
It was launched on French market in 1989 and was FDA-approved in United States in March 2013. [13] As of 2013, gadoteric acid was approved in around 70 countries. [14] [15] Dotarem is the seventh FDA-approved GBCA for use in central nervous system MRI. [citation needed]
Gadobutrol is a medicinal product used in diagnostic magnetic resonance imaging (MRI) in adults and children. It provides contrast enhancement during cranial, spinal, breast, or other investigations. In the central nervous system, Gadobutrol works by highlighting any areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity.
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