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The company received FDA 510(k) clearance for the Aurora dual-head SPECT/CT and Clarify DL imaging tech.
May 6, 2025
By: Sam Brusco
GE HealthCare has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aurora nuclear medicine system and Clarify DL. The dual-head SPECT/CT was designed to boost diagnostic capabilities and streamline workflows to provide image quality and operational efficiency.
Aurora’s 40 mm detector touts twice the detector coverage compared to CTs of other hybrid systems, according to the company. It also offers 128-slice and intelligent imaging capabilities to support applications in cardiology, oncology, and neurology.
The SPECT/CT’s 5/8-inch crystal Nal detectors make it suitable for a range of clinical radiopharmaceuticals, including those used in the rapidly changing field of theranostics. Further, Aurora has a suite of Effortless Workflow tools that offer automation and design innovations, as well as boost patient comfort.
Clarify DL provides image quality performance without needing to increase injected dose or scan time. It leverages deep learning tech to enhance bone SPECT image quality. GE HealthCare said that in a clinical evaluation, Clarify DL’s image resolution was rated better in 98% of the exams.
The company introduced Clarify DL at this year’s European Society for Therapeutic Radiology and Oncology (ESTRO) 2025 Congress.
“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. 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.”
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