Qiagen Secures European IVDR Certification For QIAGEN Clinical Insight Interpret, Its Clinical Decision Support Software
Portfolio Pulse from Benzinga Newsdesk
Qiagen has announced that its clinical decision support software, QIAGEN Clinical Insight Interpret, has received the European IVDR certification. This certification allows the software to be used for NGS molecular profiling of hereditary and somatic diseases within the EU.
May 14, 2024 | 8:09 pm
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Qiagen's receipt of the European IVDR certification for its Clinical Insight Interpret software is a significant regulatory milestone. This certification enhances the software's credibility and marketability within the EU, potentially increasing Qiagen's revenue from sales of this software.
The IVDR certification is a critical regulatory approval that allows medical devices and software to be marketed within the European Union. For Qiagen, receiving this certification for its Clinical Insight Interpret software not only validates the software's quality and compliance with EU standards but also significantly enhances its marketability and potential adoption by healthcare providers in the EU. This development is likely to be viewed positively by investors, as it opens up new revenue opportunities for Qiagen in a major market.
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