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IQ-AI Limited hails US Food & Drug Administration approval for virtual liver biopsy

The plan now is to 'actively market' the product in the US

IQ-AI Limited -

IQ-AI Limited (LON: IQAI) said it has received US regulatory clearance for a virtual biopsy that can help assess chronic liver disease.

The group noted that it has received US Food & Drug Administration 510(k) market clearance for the Liver Surface Nodularity (LSN) software developed by AI Metrics.

IQ-AI unit, Imaging Biometrics, has the global rights to manufacture, market, and distribute the technology, which presents a new way to analyse CT scans for conditions including liver inflammation, early fibrosis, advanced fibrosis, and cirrhosis.

Over 2bn people worldwide have some form of chronic liver disease that currently requires painful liver biopsies that can cost anywhere up to US$3,000 a time and are prone to errors that may result in misdiagnosis.

European regulatory sign-off for LSN in the form of a CE Mark is expected later this quarter, IQ-AI said.

“Now that the FDA has granted market clearance, Imaging Biometrics and AI Metrics will begin to actively market and sell LSN in the USA,” investors were told in a statement.

Quick facts: IQ-AI Limited

Price: 8.6 GBX

Market: LSE
Market Cap: £14.63 m


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