GE HealthCare’s Vizamyl Receives Expanded FDA Approval for Quantitative Alzheimer’s Amyloid Detection

GE HealthCare Technologies Inc. (NASDAQ:GEHC) is one of the best up and coming stocks to invest in now. On June 24, On June 24, 2025, GE HealthCare announced that the US FDA approved an updated label for its Vizamyl (flutemetamol F 18 injection) PET imaging agent, which is used for beta-amyloid detection.

The immediate update expands the agent’s indications, which allows for quantitative analysis of Vizamyl scans, and removes several prior limitations. Previously, amyloid diagnostics like Vizamyl provided a visual assessment of amyloid plaque in the brain. With the new label, clinicians can now use quantitative analysis software to objectively calculate amyloid load.

GE HealthCare's Vizamyl Receives Expanded FDA Approval for Quantitative Alzheimer's Amyloid Detection

A radiologist in a lab examining a computed tomography scan of a patient.

The removal of the therapy monitoring limitation means Vizamyl can now be used to determine if amyloid plaque levels have sufficiently reduced to consider discontinuing therapy. The updated label also explicitly indicates Vizamyl’s use for selecting patients eligible for anti-amyloid therapy. Vizamyl was initially approved in 2013 to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment.

GE HealthCare Technologies Inc. (NASDAQ:GEHC) develops, manufactures, and markets products, services, and digital solutions used in the diagnosis, treatment, and monitoring of patients.

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Disclosure: None. This article is originally published at Insider Monkey.