May 31, 2022 — Imaging Biometrics, LLC (IB), a subsidiary of IQ-AI Limited, announced it has submitted an FDA 510(k) application for IB Zero G. The patented artificial intelligence (AI) software that eliminates the need for gadolinium-based contrast agents (“GBCAs”) in routine magnetic resonance imaging (“MRI”) exams. The zero-dose GBCA exam offers potential benefits which include reduced concerns associated from the long-term side effects of repeated GBCA use, a more comfortable patient experience, and more productive radiology departments.
The FDA 510(k) submission is the first step in potentially transforming the global GBCA market and introducing a paradigm shift in radiology departments. Eliminating the need to intravenously inject GBCAs, without compromising the diagnostic quality of MRI exams, has the potential to benefit millions of patients annually. Patients with reduced kidney function who cannot tolerate GBCAs, children, and others where there are concerns about the potential effects of gadolinium retention in the body are particularly relevant to the availability of a zero-dose alternative.
“In addition to the potential benefits of eliminating or reducing the routine use of GBCAs, the recent world-wide shortages of iodinate contrast agents have illustrated how vulnerable routine radiology operations have become to the continuation of smooth-running global supply chains which we have previously taken for granted,” said Trevor Brown, CEO of IQ-AI Limited.
For more information: www.imagingbiometrics.com