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GE receives FDA clearance for its MIMneuro Centiloid scaling tool

por Lauren Dubinsky, Senior Reporter | September 18, 2024
Alzheimers/Neurology Molecular Imaging
GE's MIMneuro Centiloid scaling tool
GE HealthCare has received 510(k) clearance from the FDA to perform Centiloid scaling for PET-based amyloid imaging analysis and quantification. This capability is now available on its vendor-neutral MIMneuro Centiloid scale tool, which can help clinicians have more confidence when determining the density of amyloid plaque in a patient's brain.

"The Centiloid method has the advantage of providing a tracer and reference independent, standardized value that is therefore easy to interpret for the imager and the referring physician," Anja Mett, global product leader for neurology at GE, told HCB News. "Having a quantitative software, such as MIMneuro, that has the Centiloid method integrated, allows the user to compute these results in an easy and automated way."

An international team of clinicians and researchers developed the Centiloid scale in 2015 to standardize quantitative amyloid imaging analysis across radiotracers and institutions. With this scale, clinicians can compare amyloid results — zero being the average value from high-certainty amyloid-negative patients and 100 being the average value from typical patients with Alzheimer's disease.
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MIMneuro with Centiloid scaling provides clinicians with an automated workflow to guide them through generating and understanding the quantitative result. It analyzes PET images and gives instructions to automatically generate those quantitative results and then presents that data in a standardized report to view along with the images.

"The Centiloid scale gives referring physicians, radiologists, and researchers a common language that doesn’t vary based on radiotracer, [so that] everyone can rely on one standardized value to assess a patient’s amyloid plaque density," said Mett. "Technically, it is possible for users to replicate the Centiloid method, but it would require access to a quantitative pipeline and time to individually validate this pipeline according to published methods, making it quite an effort to execute independently."

MIMneuro with Centiloid scaling is GE's latest addition to its Alzheimer's disease care pathway solutions. Amyloid-targeting therapies have only recently been cleared for clinical use and software tools for Centiloid scaling are also a relatively recent development, according to Mett.

He explained that MIMneuro is a vendor-neutral solution that enables clinicians to use it with their existing imaging equipment. It also features a wide range of options to customize the display of amyloid PET images and other image modalities.

MIMneuro will be on display at upcoming global conferences including the Society of Nuclear Medicine & Molecular Imaging Therapeutics Conference, the Congress of the European Association of Nuclear Medicine, and the Radiological Society of North America Annual Meeting.

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