GE Healthcare Secures FDA Approval for Its Alzheimer’s Imaging Software

GE Healthcare Secures FDA Approval for Its Alzheimer’s Imaging Software

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GE Healthcare has been granted FDA’s 510(k) authorization for its Centiloid scale tool designed to help clinicians diagnose Alzheimer’s disease based on the density of amyloid plaque in a patient’s brain from PET scans.

Amyloid is a special type of protein often clumped up into toxic plaques in the brain in cases of Alzheimer’s, resulting in symptoms such as memory loss, according to scientists.

PET radiotracers help clinicians visualize amyloid plaque density and assess people with symptoms of impairments for Alzheimer’s. The tool can also help monitor the treatment response of patients with Alzheimer’s.

Led by Philip Rackliffe, Kevin O’Neill, Peter Arduini, Jan Makela, and Thomas Westrick, the company focuses on providing innovative and transformational medical technology and services. It specializes in information technology, medical technology, medical diagnostics, drug discovery, patient monitoring and more.

GE Healthcare Centiloid Scale

GE Healthcare researchers developed the Centiloid scale to help maintain standard amyloid imaging measures. The Centiloid scale ranges from 0 to 100. Zero represents the average value for individuals who are negative for amyloid, while 100 represents the average value for individuals with Alzheimer’s, according to GE Healthcare.

The unveiling of the Centiloid scale for PET scanners with Mimneuro follows GE Healthcare’s acquisition of Mim Software in April to support amyloid imaging.  Mimneuro is vendor-neutral software and compatible for use with PET tracers from many vendors.

The software generates standardized tracer uptake values for specific areas of the brain targeted and presents a simplified report to clinicians, helping them make informed decisions.