RE: Great Board today23 Nov 2020 14:13
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