GE HealthCare’s Flyrcado gets FDA approval for CAD detection By Investing.com

ARLINGTON HEIGHTS, Ill. – GE HealthCare (NASDAQ: NASDAQ:) has received U.S. Food and Drug Administration (FDA) approval for Flyrcado™ (flurpiridaz F 18) injection, a new positron emission tomography (PET) myocardial perfusion imaging (MPI) agent. Flyrcado is designed for the detection of coronary artery disease (CAD) and offers higher diagnostic efficacy compared to the current standard, single-photon emission computed tomography (SPECT) MPI.

Flyrcado’s approval is based on its performance in the AURORA Phase III trial, which demonstrated its effectiveness in detecting CAD. It is indicated for use in adult patients with known or suspected CAD to evaluate myocardial ischemia and infarction. The radiotracer has a half-life of 109 minutes, significantly longer than existing PET MPI tracers, which allows for broader distribution without the need for on-site production and generator maintenance. This extended half-life also enables the combination of exercise stress testing with cardiac PET imaging, which is a new development for CAD evaluation.

Dr. Jamshid Maddahi, the principal investigator of the Flyrcado clinical trials, highlighted the significance of Flyrcado in the field of nuclear cardiology, emphasizing its potential as a game changer in diagnosing the world’s highest mortality-rate disease. Dr. Mouaz Al-Mallah, Director of Cardiac PET at Houston Methodist Hospital, noted the favorable combination of imaging agent pharmacology and convenience offered by Flyrcado, which may lead to its wider adoption in imaging centers.

Flyrcado is expected to become available in initial U.S. markets in early 2025, with broader availability to follow. The product is part of GE HealthCare’s portfolio of FDA-approved molecular imaging PET products, which also includes Cerianna™ for detecting estrogen receptor-positive lesions in breast cancer patients and Vizamyl™ for estimating beta amyloid neuritic plaque density in patients evaluated for Alzheimer’s disease or cognitive decline.

The approval of Flyrcado marks a significant advancement in the diagnostic options available for CAD and reflects GE HealthCare’s commitment to innovation in molecular imaging. The company is a global leader in the field, supporting over 120 million patient procedures annually.

This news article is based on a press release statement from GE HealthCare.

In other recent news, GE HealthCare has made several significant advancements. The company introduced its latest developments in radiation oncology at the American Society for Radiation Oncology conference, with innovations designed to streamline the radiation therapy process. GE HealthCare also announced a quarterly cash dividend of $0.03 per share, reflecting its commitment to providing returns to investors.

UBS downgraded GE HealthCare’s stock from Neutral to Sell due to potential risks from the Chinese market and a lower growth outlook. However, BTIG upgraded the company’s rating from Neutral to Buy due to a favorable outlook for the second half of the year.

GE HealthCare initiated a secondary underwritten public offering of 10 million shares of its common stock, led by Morgan Stanley & Co. LLC and Citigroup. A trial demonstrated the effectiveness of GE HealthCare’s End-tidal Control software in delivering inhaled anesthesia, indicating potential for reducing anesthetic agent usage.

The company reported Q2 revenues of $4.84 billion and earnings per share of $1.00, nearly matching Wall Street expectations. Despite market headwinds in China, the company maintained its earnings guidance for the year and raised its guidance for adjusted earnings before interest and taxes margin expansion. These are recent developments in GE HealthCare Technologies’ operations.

InvestingPro Insights

GE HealthCare’s recent FDA approval for Flyrcado aligns well with its strong market position and financial performance. According to InvestingPro data, the company boasts a market capitalization of $42.24 billion, reflecting its significant presence in the healthcare equipment sector. This is further supported by an InvestingPro Tip indicating that GEHC is a “prominent player in the Healthcare Equipment & Supplies industry.”

The company’s innovative approach to cardiac imaging, as demonstrated by Flyrcado, is likely contributing to its solid financial metrics. GE HealthCare reported a revenue of $19.52 billion in the last twelve months, with a gross profit margin of 40.96%. These figures suggest a strong market demand for the company’s products and services, which could be further bolstered by the introduction of Flyrcado.

Another InvestingPro Tip notes that the stock has shown a “strong return over the last three months,” with a 17.39% price total return in that period. This positive momentum could be partly attributed to investor optimism surrounding developments like the Flyrcado approval.

For investors seeking more comprehensive analysis, InvestingPro offers 7 additional tips for GE HealthCare, providing deeper insights into the company’s financial health and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.