LONDON: IQ-AI Limited announced that the US Food and Drug Administration (FDA) has granted 510(k) market clearance for the Liver Surface Nodularity (LSN) software application.
Earlier this year, IQ-AI’s subsidiary, Imaging Biometrics, LLC (“IB”), entered into a business agreement with the owners of LSN, AI Metrics, LLC, which granted IB global rights to manufacture, market, and distribute the LSN software platform.
Now that the FDA has granted market clearance, IB and AI Metrics will begin to actively market and sell LSN in the USA. CE mark for European distribution and commercialisation is expected later this quarter.
LSN presents a new way to use CT scans for virtual liver biopsy to help assess individuals with chronic liver disease (CLD).
CLD is a serious condition that progresses through various stages including liver inflammation, early fibrosis, advanced fibrosis, and cirrhosis. In total, over 2 billion people worldwide have some form of CLD which requires frequent monitoring for proper staging and treatment.
Currently, the best way to monitor liver deterioration due to CLD is by undergoing a liver biopsy. The problem with liver biopsies is that they can be quite painful to the patient and expensive. A single liver biopsy can cost between $2,000 and $3,000 per test and is associated with a risk of bleeding. Biopsy sampling is also prone to errors which may result in misdiagnosis.
LSN’s proprietary algorithms process CT images of a patient’s liver to assess the nodules along the liver surface. This low cost, low-risk, non-invasive procedure provides physicians with new information that may aid in the staging of CLD and has the potential to become the standard of care for a significant global market.
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.