BioNTech Acquires Chinese Oncology Firm Biotheus for $950M

The Care and Protection of Children Trust

CPCT Launches Groundbreaking Initiative to Provide Lifelong Free Treatment for Children with Spinal Muscular Atrophy (SMA) in Karnataka

Early Comprehensive Genomic Profiling Improves Cancer Treatment Outcomes, Study Shows

EMA Reverses Decision, Recommends Limited Approval for Eisai and Biogen’s Alzheimer’s Drug Leqembi

Exact Sciences Unveils Advances in Multi-Cancer Early Detection with Cancerguard™ Test

MSD and LaNova Medicines Enter Exclusive Global License Agreement for Novel Cancer Therapy, LM-299

Promising CAR T Cell Therapies from BMS and Cabaletta Bio Show Potential for Durable Remission in Severe Lupus

FDA Grants Accelerated Approval to PTC Therapeutics' KEBILIDI™, the First Gene Therapy for AADC Deficiency in the U.S.

Association for Molecular Pathology Publishes Joint Consensus Report on SARS-CoV-2 Genomic Surveillance for Hospitals and Public Health Laboratories

Philips India Unveils Advanced Azurion Imaging System to Revolutionize Cardiac and Neurovascular Care

Tempus AI Study Highlights Benefits of Dual RNA and DNA Sequencing for Advanced Lung Cancer

Ontada and Datavant Partner to Expand Access to Real-World Oncology Data for Accelerated Cancer Innovation

Tempus AI and Flatiron Health Partner to Integrate Genomic Testing into OncoEMR for Enhanced Oncology Care

Flare Therapeutics and Roche Forge Strategic Partnership to Discover Precision Oncology Therapies Targeting Transcription Factors

FDA Approves Autolus’s CAR-T Therapy Aucatzyl for Relapsed or Refractory B-ALL in Adults

Home
/
update
/
details

GE HealthCare's MIM Software Receives FDA Clearance for New Centiloid Scaling Tool to Quantify Amyloid Plaque in Brain Imaging

NextEdge Admin

19 Sep 2024

2 min 57 sec

GE HealthCare’s MIM Software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Centiloid scaling tool, designed to quantify amyloid plaque in positron emission tomography (PET) brain imaging. The tool is integrated with MIMneuro, a vendor-neutral platform that assists clinicians in assessing amyloid plaque density, a key biomarker in Alzheimer’s disease.

Alzheimer’s disease accounts for 60-80% of dementia cases, affecting over 6 million Americans. This number is projected to reach nearly 13 million by 2050. Alzheimer’s progressively impairs memory, cognition, and behavior, leading to severe impairment that disrupts daily life. A significant hallmark of the disease is the accumulation of beta-amyloid plaques, which is associated with brain cell death and tissue loss. The ability to quantify these plaques is crucial for diagnosis and treatment.

Recent advancements in amyloid-targeting therapies offer new hope, showing potential to slow cognitive decline in Alzheimer’s patients. PET imaging plays a critical role in identifying candidates for these treatments by visualizing and quantifying amyloid protein. To standardize amyloid imaging results across different tracers and institutions, the Centiloid scale was developed by an international team of experts. The scale ranges from zero, representing amyloid-negative patients, to 100, representing typical Alzheimer’s cases.

MIMneuro with Centiloid scaling provides an automated workflow that helps clinicians generate and interpret quantitative results. The software takes PET amyloid images and produces standardized reports, enhancing clinician confidence in estimating plaque density. This, in turn, can improve decision-making for amyloid-targeting therapies.

“Centiloid scaling with MIMneuro offers a standardized metric to help clinicians confidently estimate amyloid plaque density,” said Andrew Nelson, CEO of MIM Software, GE HealthCare. This innovation aims to broaden patient access to personalized Alzheimer’s care and contribute to the growing portfolio of GE HealthCare’s solutions for the Alzheimer’s disease care pathway.