27th Sep 2019 15:31
(Alliance News) - Feedback PLC said Friday it is aware the licensee of its TexRAD medical imaging software, Stonechecker, has received clearance from the US Food & Drug Administration for marketing in the US.
Stonechecker, owned by London-listed IQ-AI Ltd's US subsidiary Imaging Biometrics, is a medical software designed to aid clinical decision making by providing information about a patient's kidney stone.
Shares in IQ-AI trebled Friday on the news, rising to 11.46 pence after closing Thursday at 4.60p. Feedback also rose 13% on the news, jumping to 1.22p.
Feedback stressed, however, it was unclear how it would be affected by the FDA clearance.
Feedback said Stonechecker is a licensee of TexRAD, which is Feedback's medical imaging software. Feedback said it believes the Stonechecker software uses TexRAD but is unsure how the FDA clearance given to Stonechecker affects TexRAD.
Feedback noted it is "currently not able to evaluate what level of income, if any, will accrue" from Stonechecker's FDA clearance but is now "evaluating the implications" as part of its "ongoing strategic review".
In May 2018, IQ-AI first submitted an application for StoneChecker to the FDA for testing, but the process was delayed by requests for further information in October and the US government shutdown in February 2019.
By Paul McGowan; [email protected]
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