GE MEDICAL SYSTEMS

FDA approves flurpiridaz F-18 (Flyrcado; GE Healthcare) for CAD diagnosis, offering improved PET imaging accuracy, especially for patients with high BMI and women. Expected U.S. release in early 2025.

FDA approves flurpiridaz F-18 (Flyrcado) for PET imaging in CAD patients, offering improved diagnostic accuracy over SPECT MPI. Clinical trials showed sensitivity of 74-89% and specificity of 53-70% in detecting significant CAD, with potential benefits for hard-to-image patients. GE Healthcare plans to release Flyrcado in the U.S. in early 2025.

FDA approves flurpiridaz F-18 (Flyrcado) for CAD diagnosis, offering improved PET imaging accuracy over SPECT MPI, with extended half-life and confirmed efficacy in clinical trials. GE Healthcare to release in 2025.

GE Healthcare received FDA approval for Flyrcado, a new PET imaging agent with a longer half-life to detect coronary artery disease, offering higher diagnostic efficacy and expanding access to PET MPI. The agent's longer half-life allows for offsite manufacturing and delivery, potentially improving accuracy for patients with high BMI and women. GE Healthcare plans to roll out Flyrcado in the U.S. in early 2025.

Evidia, a prominent radiology provider, collaborated with GE HealthCare to address operational challenges through the introduction of GE’s Imaging 360. This solution standardized protocols, streamlined scheduling, and enabled remote assistance, leading to improved efficiency, reduced wait times, and consistent image quality across Evidia’s diverse facilities.

GE Healthcare's diagnostic agent Flyrcado, approved by the FDA for coronary artery disease detection, is expected to launch in 2025 with peak annual sales potential of $1 billion, boosting EPS by 80 cents by 2028. This, along with lower borrowing costs and China's stimulus, has made GE Healthcare one of the top-performing stocks in Q3, with shares up over 19%.

FDA approves GE Healthcare's Flyrcado, a PET imaging agent for CAD detection, offering superior diagnostic quality to SPECT MPI. With a 109-minute half-life, it enables off-site manufacturing and multiple cardiac exams. Available in early 2025.

FDA approves Flyrcado™ for PET MPI in CAD patients; supported by 2 trials showing sensitivity 74-89% and specificity 53-86% at 50% stenosis threshold; common adverse reactions include dyspnea and headache; longer half-life allows offsite manufacturing and combined stress testing with PET imaging; availability expected in early 2025.

Sept. 30, 2024 – FDA-approved drug Flyrcado (flurpiridaz) improves CAD diagnosis via PET scans, overcoming challenges of other radiotracers. It can be produced off-site and lasts 109 minutes, enhancing testing efficiency. Studies show it effectively detects CAD in women and obese individuals, with availability starting early 2025.

FDA approves ¹⁸F flurpiridaz PET radiotracer for evaluating suspected MI and ischemia in CAD patients, based on trials showing superiority over SPECT.