This section highlights FDA-related milestones and regulatory updates for drugs developed by GE HealthCare Technologies (GEHC).
Over the past two years, GE HealthCare Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Cerianna, Flyrcado, macrocyclic, and Vizamyl. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Cerianna - FDA Regulatory Timeline and Events
Cerianna is a drug developed by GE HealthCare Technologies for the following indication: For Lobular Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cerianna
- Announced Date:
- May 30, 2025
- Indication:
- For Lobular Breast Cancer
Announcement
GE HealthCare announced that the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)for clinicians now recommend considering fluoroestradiol (FES) positron emission tomography (PET) for systemic staging in patients with recurrent or metastatic lobular breast cancer.
AI Summary
GE HealthCare announced that the NCCN Guidelines® now recommend using fluoroestradiol (FES) PET for systemic staging in patients with recurrent or metastatic lobular breast cancer. This update highlights GE HealthCare’s Cerianna™ (fluoroestradiol F18) injection—currently the only FDA-approved imaging agent for detecting estrogen receptor positive (ER+) lesions in breast cancer. The recommendation is important because lobular breast cancer is often hard to detect with standard imaging, and it can recur in unexpected places, such as the bones or liver. With FES PET, clinicians may achieve greater diagnostic accuracy, which can lead to earlier treatment decisions and interventions. Additionally, the new guideline may help secure broader insurance coverage, ensuring that patients receive the comprehensive assessment needed to guide effective treatment strategies.
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Flyrcado - FDA Regulatory Timeline and Events
Flyrcado is a drug developed by GE HealthCare Technologies for the following indication: for enhanced diagnosis of coronary artery disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Flyrcado
- Announced Date:
- September 27, 2024
- Indication:
- for enhanced diagnosis of coronary artery disease
Announcement
GE HealthCare announced that the U.S. Food and Drug Administration (FDA) has granted approval of Flyrcado™ (flurpiridaz F 18) injection, a first of its kind positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the detection of coronary artery disease (CAD).
AI Summary
GE HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved Flyrcado™ (flurpiridaz F 18) injection, the first positron emission tomography myocardial perfusion imaging (PET MPI) agent of its kind for detecting coronary artery disease (CAD). Designed for patients with known or suspected CAD, Flyrcado offers higher diagnostic accuracy compared to the more commonly used SPECT MPI procedure. Its longer half-life—over ten times that of current cardiac PET tracers—allows offsite manufacturing and distribution to a wider network of imaging centers. This feature also provides the unique opportunity to combine exercise stress testing with PET imaging, enhancing the evaluation of myocardial ischemia. Delivered as a ready-to-use unit dose, Flyrcado may expand access for both clinicians and patients, especially for those who face challenges with traditional imaging techniques.
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macrocyclic magnetic resonance imaging - FDA Regulatory Timeline and Events
macrocyclic magnetic resonance imaging is a drug developed by GE HealthCare Technologies for the following indication: MRI Contrast Agent.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- macrocyclic magnetic resonance imaging
- Announced Date:
- October 7, 2024
- Indication:
- MRI Contrast Agent
Announcement
GE HealthCare announced the completion of its Phase I clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent.
AI Summary
GE HealthCare announced the completion of its Phase I clinical development program for a first-of-its-kind manganese-based macrocyclic MRI contrast agent. In this first-in-human study, presented at the Contrast Media Research symposium in Oslo, Norway, the agent was well tolerated by patients, with no serious adverse events, dose-limiting toxicities, or significant issues reported. The trial showed that the new agent has imaging capabilities similar to gadolinium-based products, potentially offering a safe alternative.
Since manganese is naturally present in the body and eliminated efficiently, this agent could reduce the risks of tissue buildup and environmental impact associated with gadolinium. These promising Phase I results support continued clinical development, furthering GE HealthCare’s efforts to expand its portfolio of imaging agents that are designed to meet radiologists’ needs and improve patient care.
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Vizamyl - FDA Regulatory Timeline and Events
Vizamyl is a drug developed by GE HealthCare Technologies for the following indication: For beta-amyloid detection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Vizamyl
- Announced Date:
- June 24, 2025
- Indication:
- For beta-amyloid detection.
Announcement
GE HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved an updated label for its positron emission tomography (PET) imaging agent VizamylTM (flutemetamol F 18 injection) for beta-amyloid detection.
AI Summary
GE HealthCare announced that the U.S. FDA approved an updated label for its PET imaging agent Vizamyl (flutemetamol F 18 injection) used for beta-amyloid detection. The new label now includes a quantification feature that allows clinicians to measure the level of amyloid plaques in the brain more accurately, using dedicated software to calculate amyloid load. This updated approach offers a more objective assessment compared to the previous visual-only method.
Additionally, the label change expands Vizamyl’s use, enabling healthcare providers to monitor patient responses to anti-amyloid therapies. This helps in determining when treatment can be adjusted or stopped based on changes in plaque density. Overall, the FDA’s update supports clearer diagnoses and more personalized treatment strategies for Alzheimer’s disease and related cognitive impairments.
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