GE Healthcare's Alzheimer's Imaging Software MIMneuro Receives FDA 510(k) Clearance with Centiloid Scale Integration
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GE Healthcare's Alzheimer's Disease Imaging Software Receives FDA Approval
This license adds a Centiloid Scale tool to GE Healthcare's Mim software to help clinicians determine the density of amyloid plaques.
GE Healthcare's MIM Software Receives FDA 510(k) Clearance for Assisting Physicians in Determining Amyloid Plaque Density in Brain Imaging.
GE Healthcare said on Tuesday that it has received 510(k) approval for a tool designed to help clinicians assess individuals who may have Alzheimer's disease.
This license adds a Centiloid Scale tool to GE Healthcare's Mim software, enabling clinicians to determine the density of amyloid plaques in a patient's brain from PET scans. Amyloid is a protein that accumulates into toxic plaques in the brains of Alzheimer's patients. Scientists have linked the formation of these plaques to symptoms such as memory loss.
Researchers developed the Centiloid scale, which Eisai and Eli Lilly used in developing their recently approved Alzheimer's disease drugs to standardize amyloid imaging measurements.
PET Radiotracers Help Visualize Amyloid Plaque Density, Enabling Clinicians to Assess Alzheimer's Disease in Patients with Cognitive Impairment and Evaluate Their Response to Treatment. However, Different Centers Have Reported Different PET Tracer Retention Metrics. The Variability in the Development of the 2015 Centiloid Scale Led to This.
GE Healthcare stated in a press release that the Centiloid scale ranges from 0 to 100, where 0 represents the average value for "high-quality" amyloid-negative patients, and 100 represents the average value for typical Alzheimer's patients.
In recent years, with the introduction of plaque-targeting drugs to the market, the demand for tools to assess amyloid through PET scans has increased. Last year, the Centers for Medicare and Medicaid Services changed its policy on PET scans, clearing the way for their use in evaluating patients with Alzheimer’s disease.
GE Healthcare's acquired software will support amyloid imaging upon the acquisition of Mim Software in April. Now, the company is introducing the Centiloid scale to PET scanners through its vendor-neutral software, Mimneuro. The workflow generates standardized tracer uptake values for targeted regions of the brain and presents the data to clinicians in reports.
Although GE Healthcare now owns Mimneuro, the software is compatible with PET tracers from multiple suppliers. GE Healthcare's Vizamyl, as well as Lilly's Amyvid and Life Molecular Imaging's Neuraceq, are all supported. James Saccaro, GE Healthcare’s Chief Financial Officer, said on an earnings call in July that Vizamyl sales are currently "a few million dollars," but the company expects revenue to grow as the adoption rate of Alzheimer's therapies increases.
GE Healthcare also sells PET scanners. Mimneuro provides GE Healthcare with further opportunities to tap into the growth potential of Alzheimer's disease, enabling the company to generate sales even when clinicians use PET products from other suppliers.
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