GE HealthCare announces FDA 510(k) clearance for Aurora and Clarify DL

GE HealthCare announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance of its impressive Aurora nuclear medicine system and Clarify DL. This advanced dual-head SPECT/CT is designed to enhance diagnostic capabilities and streamline workflows, offering clinicians excellent image quality and operational efficiency.

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.

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 systems – and 128-slice 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.

Designed to build on this performance, Clarify DL offers excellence image quality performance without having to increase injected dose or scan time. Leveraging advanced deep learning technology – a type of artificial intelligence – Clarify DL works to enhance bone SPECT image quality performance with clear, accurate, and effortless imaging – an essential factor in increasing diagnostic confidence. In a clinical evaluation, Clarify DL’s image resolution was rated as better in 98% of the exams, demonstrating its potential to transform nuclear medicine bone SPECT imaging diagnostics. Unlike traditional noise reduction techniques that may compromise contrast and resolution, Clarify DL is designed to optimize reconstruction without sacrificing image quality.

Additionally, Aurora is equipped with a collection of Effortless Workflow solutions to help ease technologists’ work from pre-scan to post-scan with various automation and design innovations as well as help enhance patient comfort – including those with high BMI.