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Congenica Receives CE Mark for Genomic Analysis Software
Cambridge, United Kingdom -
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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. ....

United Kingdom , David Daley , Kostenloser Wertpapierhandel , Chris Gardner , Noah Konig , David Atkins , Angela Gray , Regulatory Affairs , Genomic Medicine Service , Genomic Analysis Software , Wellcome Sanger Institute , Consilium Strategic Communications , Congenica Receives , Genomic Analysis , Vitro Diagnostics Directive , Vitro Diagnostic , Chief Executive Officer , Senior Director , Quality Assurance , Vitro Diagnostics , Clinical Decision Support , ஒன்றுபட்டது கிஂக்டம் , டேவிட் டேலி , கிறிஸ் கார்ட்னர் , நோவா கோனிக் , டேவிட் அட்கின்ஸ் ,