FDA Approves Neuraceq for Brain Imaging

The U.S. Food and Drug Administration has approved Piramal Imaging’s Neuraceq, a positron emission tomography imaging agent to aid in diagnosing dementia, according to a company news release.

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Neuraceq, or florbetaben F18 injection, can help estimate the density of neuritic plaque in the brain for patients who are under evaluation for Alzheimer’s disease or other forms of cognitive decline, according to the news release.

If a Neuraceq scan shows little to no neuritic plaque, it indicates a lesser likelihood that the patient’s cognitive impairment is due to Alzheimer’s, according to the news release.

While the imaging agent “does not establish the diagnosis of AD or any other cognitive disorder,” it’s estimation of neuritic plaque density is a tool to help physicians determine an eventual diagnosis, according to the release.

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