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ARLINGTON HEIGHTS, Ill. - The U.S. Food and Drug Administration has approved an updated label for GE HealthCare’s (NASDAQ:GEHC) Vizamyl, a positron emission tomography imaging agent used to detect beta-amyloid in the brain. The company, with a market capitalization of $32.58 billion and annual revenue of $19.8 billion, is a prominent player in the Healthcare Equipment & Supplies industry, according to InvestingPro data.
The revised label, effective immediately, now includes quantification capabilities that allow for more objective measurement of amyloid plaque density. This enables clinicians to calculate amyloid load using specialized software, potentially improving diagnostic confidence and consistency. The company maintains a healthy gross profit margin of 42%, demonstrating strong operational efficiency in its medical technology developments.
Additionally, the FDA removed previous limitations on using Vizamyl to monitor patient response to anti-amyloid therapies. The updated label now explicitly permits the use of Vizamyl to predict the development of dementia due to Alzheimer’s disease, select patients for anti-amyloid therapies, and establish an Alzheimer’s diagnosis.
"The inclusion of quantification and removal of the therapy monitoring limitation from the Vizamyl label is good news for healthcare providers and their patients," said Jit Saini, Chief Medical Officer of GE HealthCare’s Pharmaceutical Diagnostics division, according to the press release.
Phillip Kuo, Professor of Radiology at City of Hope National Medical Center, noted that quantification "can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer’s disease and determining when it can be discontinued."
Vizamyl was first approved in 2013 to estimate beta-amyloid neuritic plaque density in adults with cognitive impairment. The imaging agent is part of GE HealthCare’s Molecular Imaging portfolio, which supports approximately 130 million procedures annually worldwide.
The most common adverse reactions reported in clinical trials included flushing, increased blood pressure, headache, nausea, and dizziness. Trading at a P/E ratio of 14.09, InvestingPro analysis suggests GE HealthCare is currently undervalued, with additional ProTips and comprehensive financial analysis available through the Pro Research Report, which offers deep-dive analysis of 1,400+ top US stocks.
In other recent news, GE HealthCare Technologies Inc. reported robust financial results for the first quarter of 2025, achieving a revenue of $4.8 billion, which represents a 4% organic growth. The company also saw a 12% year-over-year increase in adjusted earnings per share (EPS), reaching $1.01, and a record backlog of $20.6 billion. BTIG has reiterated its buy rating on GE HealthCare, highlighting the company’s stable growth trajectory in the medical imaging sector compared to its competitors. Additionally, GE HealthCare announced the issuance of $1.5 billion in senior unsecured notes, reflecting its ongoing capital management strategy.
The company has also integrated its proprietary features with MIM Encore software, enhancing digital imaging and workflow solutions across various medical departments. This integration follows GE HealthCare’s acquisition of MIM Software in 2024. At its recent annual stockholder meeting, GE HealthCare secured approval for executive compensation and re-elected 10 directors, while a stockholder proposal concerning termination pay arrangements was rejected.
Furthermore, GE HealthCare is facing a tariff impact, with an estimated $0.85 per share effect for 2025, but the company is actively working on mitigation strategies. Analysts from BTIG have noted that GE HealthCare is positioned for positive performance in the second half of 2025, citing favorable comparisons and increasing market share.
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