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Congenica Receives CE Mark for Genomic Analysis Software Cambridge, United Kingdom - 202 1 - Congenica, the digital health company enabling rapid and accurate analysis of complex genomic data to transform people s lives, today announces that its genomic interpretation software is now CE marked under the In Vitro Diagnostics Directive (98/79/EC). With the In Vitro Diagnostic (IVD) designation, Congenica s clinical decision support platform can make the transition from research to clinical use and be applied to the clinical diagnosis of patients with rare hereditary genomic disorders. The platform is the only CE marked IVD software for genomic diagnostics that is available either on a local infrastructure or via the cloud and can be fully integrated with existing medical records and laboratory management systems. Medical devices require the CE mark designation for use in clinical applications in several key territories including the UK and the EU. ....
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