GE HealthCare claims FDA clearance for amyloid imaging software in Alzheimer’s disease

GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease.

The automated MIMneuro program analyzes PET images from any scanner boosted by injectable radioactive tracer agents with the goal of providing a standardized metric for one of the main facets of the condition’s pathology.

It utilizes the Centiloid scale, which aims to offer consistent measurements of brain tissue across various scanners and tracers; it ranges from a score of 0 among people highly likely to have no amyloid buildups, to a high of 100 that represents the typical patient with Alzheimer’s.

With advances in pharmaceutical therapies over the past 18 months—including the FDA’s approvals of Eisai and Biogen’s Leqembi and Eli Lilly’s Kisunla—GE HealthCare has been positioning itself to provide the diagnostic support required before treatment.

“As amyloid-targeting therapies continue to show meaningful results against Alzheimer's disease, PET imaging can help clinicians more confidently determine a patient's amyloid status,” Anja Mett, GE HealthCare’s global product leader for MI neurology, said in a statement. The company estimates that, by 2050, nearly 13 million people in the U.S. will be diagnosed with Alzheimer’s.

“MIM Software’s new Centiloid scaling solution in MIMneuro is the latest addition to our growing portfolio of GE HealthCare Alzheimer’s disease care pathway solutions: including MR and PET scanners, and our amyloid PET tracer—combined with our digital solutions,” Mett added.

GE HealthCare bought the Ohio-based MIM Software through a $295 million cash deal that closed this past April. The company had previously developed medical imaging and artificial intelligence programs for radiation oncology, theranostics, molecular radiotherapy and urology, including in nuclear medicine contouring and dosimetry.