GE HealthCare has obtained the FDA’s blessing for its latest imaging system combining SPECT and CT scanning, as well as for the artificial intelligence programs that help power it.
The Aurora nuclear medicine system’s dual-head design, which integrates gamma ray-based SPECT hardware alongside X-ray CT components, expands its range of procedures across multiple specialities. Meanwhile, the Clarify DL deep learning AI works to boost image coherence and reduce noise.
The 75 cm bore scanner is also equipped with a 40 mm detector, which GE HealthCare describes as offering twice the coverage of other hybrid SPECT/CT systems, and is capable of working with a large menu of radiopharmaceutical imaging and theranostic agents employed in cardiology, oncology and neurology.
The machine, which has also received a CE Mark approval in Europe, was unveiled in the U.S. late last year at the annual meeting of the Radiological Society of North America.
With the agency’s 510(k) clearance in hand, the company announced that the University Hospitals health system in Cleveland, Ohio would be the first in the U.S. to install the scanner.
The purchase follows a long-running collaboration between the provider and GE HealthCare, with a 10-year deal covering the delivery of hundreds of new systems spanning nuclear medicine as well as ultrasound, fluoroscopy and surgery.
University Hospitals was previously the first in the U.S. to evaluate GE HealthCare’s on-device X-ray AI programs for automatically identifying critical cases, such as people with a collapsed lung.