CHICAGO — May 5, 2025 — GE HealthCare (Nasdaq: GEHC) today is proud to announce that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance of its impressive Aurora nuclear medicine system and Clarify DL.ii This advanced dual-head SPECT/CT is designed to enhance diagnostic capabilitiesi and streamline workflows, offering clinicians excellent image quality and operational efficiency.
“We are thrilled to be the first in the United States to adopt this incredibly impressive technology,” shares 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. “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.”iii
As healthcare continues to shift toward precision medicine and personalized care, clinicians require more advanced SPECT/CT solutions that provide greater diagnostic accuracy and efficiency. The ability to monitor and help tailor treatments to individual patients depends on high-quality imaging that can detect subtle disease markers with confidence. To meet these evolving needs, new technologies – like Aurora and Clarify DL – must seamlessly integrate into various clinical settings, ensuring that hospitals and imaging centers can adopt them without disrupting existing workflows.
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“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,” says 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. We are proud to be a leader in nuclear medicine and AI technologies and excited to make Aurora with Clarify DL available to healthcare systems – like University Hospitals – and clinicians throughout the United States.”
Aurora provides imaging precision, streamlines workflows, and enables an improved patient experience – marking a significant step forward in nuclear medicine. Its 40 mm detector – twice the detector coverage compared to CTs of other hybrid systemsiv – and 128-slicev plus intelligent imaging capabilities help support a wide range of clinical applications, from cardiology to oncology and neurology. Furthermore, Aurora’s available 5/8-inch crystal NaI detectors make it a suitable system for a wide range of clinical radiopharmaceuticals, including those used in the rapidly evolving field of theranostics.
