SHERIDAN, WYOMING – May 6, 2025 – GE HealthCare (Nasdaq: GEHC) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aurora dual-head SPECT/CT system and Clarify DL, a Deep Learning-powered image reconstruction solution. This milestone underscores GE HealthCare’s commitment to advancing nuclear medicine by offering solutions that drive diagnostic precision, streamline workflows, and support evolving clinical needs.
University Hospitals in Cleveland, Ohio, has become the first healthcare system in the United States to install the Aurora system. This strategic deployment reflects growing demand among providers for scalable imaging technologies that support a wide range of clinical applications while enabling a more personalized approach to patient care.
Revolutionizing SPECT/CT for Precision Medicine
Aurora is engineered to address the increasing demand for high-performance hybrid imaging in support of precision medicine. With its dual-head SPECT/CT integration and advanced AI-driven image reconstruction via Clarify DL, the system is designed to empower clinicians to detect disease earlier, more confidently, and with enhanced operational efficiency.
“Aurora and Clarify DL are powerful reflections of GE HealthCare’s ongoing investment in next-generation imaging solutions that empower clinicians to practice precision medicine and make more informed decisions,” said Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography, GE HealthCare. “By providing diagnostic precision while enabling improved workflow, these nuclear medicine technologies allow clinicians to deliver effective, patient-centered care—ultimately helping drive better outcomes.”
Key Features and Strategic Advantages
Aurora’s combination of intelligent imaging technologies and design innovations offers significant benefits to healthcare systems and clinicians, including:
- 40 mm detector coverage – Double that of standard CTs in hybrid systems, supporting wider diagnostic applications.
- 128-slice CT capabilities – Enabling high-resolution, multi-planar imaging for greater clarity.
- 5/8-inch NaI crystal detectors – Supporting broad radiopharmaceutical use, including theranostics.
- Effortless Workflow suite – Automating processes from pre- to post-scan, aiding technologists and improving patient throughput.
- Inclusive design – Accommodating a variety of patient sizes and conditions, enhancing comfort and accessibility.
The system's seamless integration allows institutions to modernize nuclear medicine services without compromising existing workflows or increasing radiation exposure.
Clarify DL: Deep Learning Meets Diagnostic Confidence
Clarify DL complements Aurora’s hardware by leveraging artificial intelligence to enhance image quality without extending scan time or increasing the injected dose. In clinical evaluations, Clarify DL improved image resolution in 98% of reviewed exams, reinforcing its impact on diagnostic confidence.
“Aurora’s seamless integration of SPECT and CT components will allow us to perform comprehensive, high-quality diagnostic exams in a single session, while its support of Clarify DL deep-learning image reconstruction enables enhanced image quality performance,” said Donna Plecha, MD, Chair Department of Radiology, Radiologist-in-Chief, and Ida and Irwin Haber and Wei-Shen Chin, MD Chair in Radiology, at University Hospitals.
Unlike conventional noise reduction techniques, Clarify DL is specifically designed to preserve contrast and structural clarity—two essential factors for accurate interpretation in complex cases such as oncology and neurology.
Enhancing Operational Efficiency and Patient Care
University Hospitals' implementation of the Aurora SPECT/CT system reflects a forward-looking approach to optimizing diagnostic services and enterprise-wide efficiency. With Revolution Ascend CT technology embedded in the system, radiology teams benefit from consistency in technology and performance.
“Patient flow and overall operational efficiency are crucial for us, making Aurora the ideal choice to help meet our needs,” noted Percival Kane, Chief Operating Officer, University Hospitals Ahuja Medical Center.
This acquisition also includes MIM Software and digital solutions, as part of a broader collaboration between GE HealthCare and University Hospitals aimed at advancing clinical decision-making and improving healthcare delivery through integrated technologies.
To learn more about GE HealthCare’s newly FDA-cleared Aurora SPECT/CT and Clarify DL, visit gehealthcare.com.