03:06 PM EDT, 06/24/2025 (MT Newswires) -- GE Healthcare Technologies ( GEHC ) said Tuesday the US Food and Drug Administration approved an updated label for its positron emission tomography imaging agent Vizamyl, which is used for beta-amyloid detection.

The updated label for Vizamyl represents an advancement in Alzheimer's care by enabling quantitative analysis with specialized software, allowing a more objective assessment of amyloid plaque levels and expanding its use beyond visual interpretation to support treatment monitoring and consistent diagnoses, the company said.

GE Healthcare ( GEHC ) said the FDA's decision removes prior restrictions on Vizamyl, allowing it to be used to monitor patient response to anti-amyloid therapies and assess whether plaque levels have decreased enough to consider stopping treatment.

The revised label, reflecting new Alzheimer's Association criteria, allows an abnormal amyloid PET scan to confirm an Alzheimer's diagnosis and removes prior limits on predicting cognitive decline, backed by data linking amyloid-positive scans to increased dementia risk, according to the health technology company.

Shares of GE Healthcare ( GEHC ) were up 1.3% in recent trading.

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