From Proactive 13/12/189 Jul 2019 13:58
READ IQ-AI receives first commercial order for StoneChecker
During a conference call at the end of October, the FDA asked for additional information to be presented to show how the product might work in situations where suboptimal computed tomography (CT) images had been obtained. In response, IQ-AI provided the FDA with additional testing methodology on 27 November for evaluation.
The FDA typically processes 95% of medical device applications within 90 days, so with less than 18 days of 2018 left, it is likely the FDA will not complete its review of the Stonechecker package until the first quarter of next year.