Imaging Biometrics Submits FDA 510(k) Application for IB Zero G

Rhea-AI Summary

Imaging Biometrics, a subsidiary of IQ-AI Limited (OTCQB:IQAIF), has submitted an FDA 510(k) application for IB Zero G, an AI software that eliminates the need for gadolinium-based contrast agents in routine MRI exams. This zero-dose technology aims to enhance patient comfort and safety, particularly for those with kidney issues or gadolinium retention concerns. The submission marks a pivotal moment in the global GBCA market, potentially transforming radiology practices by mitigating supply chain vulnerabilities highlighted by recent iodinated contrast agent shortages.

Positive

• Submission of FDA 510(k) application for IB Zero G, a significant innovation in MRI technology.
• Elimination of gadolinium-based contrast agents may enhance patient safety and comfort.
• The technology addresses supply chain issues, improving reliability in radiology operations.

Negative

• None.

Patented Artificial Intelligence Technology Eliminates the Need for Gadolinium-Based Contrast Agents in MRI Exams

MILWAUKEE, WI / ACCESSWIRE / May 31, 2022 / Imaging Biometrics, LLC (IB), a subsidiary of IQ-AI Limited, (OTCQB:IQAIF) (LSE:IQAI), today 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.

About IQ-AI Limited

IQ-AI Limited, (LON: IQAI) (OTCQB: IQAIF), the parent company of Wisconsin-based Imaging Biometrics, LLC (IB), is focused on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com.

Safe Harbor Statement

This press release includes statements that may constitute forward-looking statements made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," or the negative of these words and/or similar statements. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. For example, statements about future revenues and the Company's ability to fund its operations and contractual obligations are forward looking and subject to risks. Several important factors could cause actual results to differ materially from those contained in any forward-looking statement. Potential risks and uncertainties include, but are not limited to, the inability to raise capital to support the Company through its growth stage, the Company's inability to generate projected sales and trade relations between the United States and China. The Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Investor Relations
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Tel: 212-564-4700
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SOURCE: IQ AI Ltd.

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FAQ

What is the purpose of the FDA 510(k) application submitted by IQ-AI Limited?

The FDA 510(k) application is for IB Zero G, an AI software that eliminates the need for gadolinium-based contrast agents in MRI exams.

How does IB Zero G benefit patients?

IB Zero G provides a zero-dose alternative to gadolinium-based contrast agents, reducing risks for patients with kidney issues and those concerned about gadolinium retention.

What market impact does IB Zero G have?

IB Zero G has the potential to transform the global gadolinium-based contrast agent market by introducing a safer MRI exam alternative.

What concerns led to the development of IB Zero G?

Concerns about the long-term side effects of gadolinium use and recent iodinated contrast agent shortages prompted the development of IB Zero G.

When was the FDA 510(k) application for IB Zero G submitted?

The FDA 510(k) application for IB Zero G was submitted on May 31, 2022.