Aurora is a medical imaging system that combines nuclear medicine (SPECT) and CT imaging to help healthcare professionals detect and evaluate diseases including cardiovascular, neurological disorders, and cancer. It provides enhanced imaging through various scanning modes, real-time processing features including deep-learning based automatic kidney segmentation, and supports therapy planning and monitoring.
Intended Use
The Aurora system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body and CT imaging for enabling attenuation correction and anatomical localization of SPECT images and standalone CT applications for head, whole body, cardiac and vascular imaging. It aids in detecting, localizing, diagnosing diseases and assessment of organ function including cardiovascular disease, neurological disorders and cancer, and supports staging/restaging tumors and therapy monitoring.
Technology
Aurora is a dual gantry SPECT-CT imaging system combining a Nuclear Medicine system with planar and SPECT imaging together with a GE Revolution Ascend CT system. It includes acquisition and processing software for multiple scanning modes, image quality enhancement, CT-based attenuation correction, and anatomical mapping. It introduces a deep-learning based automatic kidney segmentation algorithm to assist with renal scintigraphy image analysis.
Performance
Performance testing included extensive bench testing and clinical testing on 70 planar nuclear medicine renal studies from multiple centers using diverse clinical scenarios and patient demographics. The automatic kidney segmentation algorithm was evaluated against expert annotated ground truth using DICE similarity scores, surpassing predefined success criteria, and confirmed by clinical readers to provide acceptable segmentation quality. Testing demonstrated safety and effectiveness equivalent to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/14/2025
1 month - 2
FDA Approval
6/12/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.