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  • Submission of FDA 510(k) Application for IB Zero G
 

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Tuesday, 31 May 2022 / Published in IQ-AI RNS News & Announcements

Submission of FDA 510(k) Application for IB Zero G

RNS Number : 3069N
IQ-AI Limited
31 May 2022
 

31 May 2022

 

IQ-AI Limited

(“IQ-AI” or the “Company”)

 

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

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

Milwaukee – 31 May 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.

The Directors of the Company accept responsibility for the contents of this announcement.

 

-ENDS-

 

For further information, please contact:

 

IQ-AI Limited

Trevor Brown/Brett Skelly/Vinod Kaushal

Tel: 020 7469 0930

 

Peterhouse Capital Limited (Financial Adviser and Broker)

Lucy Williams/Heena Karani

Tel: 020 7220 9797

 

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.

 

Market Abuse Regulation (MAR) Disclosure

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation EU 596/2014 as it forms part of retained EU law (as defined in the European Union (Withdrawal) Act 2018).

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom.
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