IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF) subsidiary Imaging Biometrics has submitted a pre-market notification to the US Food and Drug Administration in respect of its IB Zero G software.
IB Zero G is the patented artificial intelligence (AI) software that eliminates the need for gadolinium-based contrast agents (GBCA) in routine magnetic resonance imaging (MRI) exams. The zero-dose GBCA exam offers potential benefits which include reduced concerns associated with the long-term side effects of repeated GBCA use, a more comfortable patient experience, and more productive radiology departments, IQ-AI said.
The submission, known as an FDA 510(k) – a process that notifies the Food and Drug Administration of a company’s intention to introduce a device into commercial distribution for the first time – was described by IQ-AI as 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, the company asserted. 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, it added.
"In addition to the potential benefits of eliminating or reducing the routine use of GBCAs, the recent worldwide 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, the chief executive of IQ-AI.
Shares in AQ-AI were up 9.4% at 4.38p in the first hour of trading.