Virtonomy GmbH

Accelerating and de-risking medical device development with digital patient twins: Virtonomy enables medical device developers to perform development and testing in a virtual environment, thereby accelerating development, reducing risks, expenses, and regulatory burden. Our end-to-end digital twin and simulation solution is based on an ever-expanding database of real clinical data to reflect anatomical variability, demographic diversity and pathological conditions.

Founded: 2019 Headquarters:Paul-Heyse-Straße 6 ,80336

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  • Accelerate clinical trials with digital patient twins, ensure their success, reduce costs and time

    Virtonomy empowers medical device developers with v-Patients, a virtual testing and development platform enabling developers to validate their device design on digital patient twins. By leveraging our comprehensive digital twin and simulation technology, built on a constantly growing database of real clinical data (CT/MRI scans of real patients), we help developers account for anatomical differences, demographic diversity, and various medical conditions. This approach accelerates product development, minimizes risks and costs, and simplifies regulatory compliance, transforming the way medical devices are brought to market.

      • Virtonomy’s virtual trial platform supports the full product life cycle of medical device development, from concept phase to regulatory reporting and clinical practice.

         

        Thousands of Virtual Patients:

        • Virtual patient cohort tailored for you
        • Advanced 3D visualization and interactive implantation
        • Accurate 3D measurements and extensive statistics

         

        Advanced Statistical Shape Models:

        • Worst and edge-case anatomies
        • Average patient anatomy
        • Available for any customer-chosen patient group

         

        Advanced Anatomical Simulations:

        • Validated ISO benchtop test simulations
        • Validated in-human implant simulations


        Regulatory Services & Consultation:

        • Regulatory path with a virtual testing plan
        • Compliance with all regulatory bodies
        • Validated virtual evidence report

      • 2022
    • Clinical Reference
    • Clinicians, Researcher
    • Released
    • Software and Apps
    • Clinical Trials
    • Research
      • Regulatory viewpoint:

        The FDA and European Commission show strong support for virtual patients and simulation.


        "FDA’s Office of Science and Engineering Laboratories (OSEL) has committed significant resources for transforming computational modeling from a valuable scientific tool to a valuable regulatory tool because of its potential for significant cost-savings in evaluating medical devices, simulating performance under scenarios that may not be possible with human use or that could more effectively be evaluated with simulation." (Source)


        More useful links:

        FDA’s support on computational modeling

        FDA: Diverse racial and ethnic groups for clinical trials


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