IQ-AI Regulatory News (IQAI)

23 November 2020

IQ-AI Ltd

("IQ-AI" or the "Company")

LSN Software is now CE Mark Approved

IQ-AI today announces that the LSN (Liver Surface Nodularity) software application is now CE Mark approved. The CE marking confirms that LSN meets the Essential Requirements of the European Medical Devices Directive. Earlier this month, the US Food and Drug Administration ("FDA") granted 510(k) market clearance for LSN software. These recent regulatory milestones permit IQ-AI's subsidiary, Imaging Biometrics, LLC ("IB"), the manufacturer of record for LSN, to market and sell the software to the world's two most prominent healthcare markets.

LSN's proprietary algorithms process CT images of a patient's liver to assess the nodules along the liver surface. This virtual biopsy offers a low cost, low-risk, non-invasive alternative that may aid in the staging of CLD and has the potential to become the standard of care for a significant global market.

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

-ENDS-

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ABOUT Imaging Biometrics, LLC

Imaging Biometrics®, a subsidiary of IQ-AI Limited (LON:IQAI), develops and provides visualisation and analytical solutions that enable clinicians to better diagnose and treat disease with greater confidence. Through close collaboration with top researchers and clinicians, sophisticated advancements are translated into platform-independent and automated software plug-ins which can extend the base functionality of workstations, imaging systems, PACS, or medical viewers. By design, IB's advanced visualisation software seamlessly integrates into routine workflows. For more information about Imaging Biometrics, visit the company's website at www.imagingbiometrics.com.