FDA Clears Dual-Head SPECT/CT System with Deep Learning Image Reconstruction

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Aurora single photon emission computed tomography/computed tomography (SPECT/CT) system and Clarify DL deep learning image reconstruction.

GE HealthCare, the developer of the dual-head Aurora SPECT/CT system, said the device offers the following key benefits:

• a 40 mm detector offering twice the coverage of CTs from other hybrid systems;

• 128-slice capabilities across imaging applications in neurology, cardiology, and oncology; and

• a 5/8-inch crystal Nal detector, which allows use of a variety of radiopharmaceuticals including theranostics.

Through advanced deep learning technology, GE HealthCare maintained that Clarity DL image reconstruction bolsters quality for bone SPECT imaging without the need for increased radiation dosing or scan time.

“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,” noted Donna Plecha, M.D., chair of the Department of Radiology at University Hospitals Cleveland Medical Center, and a professor of radiology at the Case Western Reserve University School of Medicine in Cleveland.