GE HealthCare Claims FDA Clearance for Amyloid Imaging Software in Alzheimer's Disease

What is the News?

GE HealthCare has announced that the U.S. Food and Drug Administration (FDA) has cleared its amyloid imaging software for use in detecting brain amyloid in patients with suspected cognitive impairment or dementia due to Alzheimer's disease (AD).

The software, called Amyvid Plaque Imaging, is intended to be used with the company's Discovery NM/CT 670 PRO and Discovery MI systems. It is a radiotracer used with a Positron Emission Tomography (PET) scan to assess the level of amyloid plaque in the brain.

Why is this Important?

This clearance is significant because it provides clinicians with a valuable tool for diagnosing Alzheimer's disease, which affects an estimated 6.5 million Americans age 65 and older.

Early and accurate diagnosis of Alzheimer's disease is crucial for appropriate patient management, including treatment decisions and planning for future care.

Key Points about Amyvid Plaque Imaging

• Amyvid Plaque Imaging is a non-invasive procedure that takes approximately 20 minutes.
• The software uses a radioactive tracer called florbetapir F 18 to bind to amyloid plaques in the brain.
• The PET scan images can then be used to visualize and quantify the amyloid plaque burden in the brain.

Additional Information and Resources:

For more information about Amyvid Plaque Imaging, please visit the GE HealthCare website: https://www.gehealthcare.com/products/molecular-imaging/amyvid-plaque-imaging

To learn more about Alzheimer's disease, please visit the Alzheimer's Association website: https://www.alz.org/

Conclusion

The FDA clearance of GE HealthCare's Amyvid Plaque Imaging software is a significant advancement in the diagnosis of Alzheimer's disease. This tool will enable clinicians to make more informed decisions about patient care and help improve the lives of those affected by this devastating disease.