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Imaging expertise. Meaningful data delivered.

Imaging core lab services

In clinical trials, imaging can be intimidating. Study success hinges on high-quality data, requiring valuable resources from start to close-out.

At RAYLYTIC’s imaging core lab, we combine state-of-the-art automated image analysis technology with deep subject matter expertise with a singular goal in mind: Streamlining imaging operations in orthopedic clinical trials to provide MedTechs, CROs, and hospitals with consistent data and reliable results.

Our imaging core lab services at a glance

Over 30 implant manufacturers of all sizes have achieved success using RAYLYTIC’s imaging core lab services across various regulatory pathways, including IDE, 510(k), CE-marking, and PMCF.

Automated
image analysis

Highly precise evaluation of musculoskeletal morphology and implant performance, including:

  • Automated evaluation of over 150 quantitative radiographic parameters

  • History of successful regulatory submissions

  • Standardized quality control inspections
  • Radiologist
    Network

    RAYLYTIC uses a network of board-certified radiologists to provide:

  • Independent blind review

  • Radiological adjudication

  • Consistency and plausiblity checks
  • Imaging data
    management software

    Our UNITY platform improves the quality of 2D and 3D imaging data (X-ray, CT, MRI) in multicenter clinical trials.

  • Automated, HIPAA-compliant image de-identification and transfer

  • Site-friendly upload of images

  • Automated image quality control
  • Scientific
    consultations & medical writing

    We are acknowledged authorities in musculoskeletal research and provide:

  • Recommendations for imaging-related elements of clinical trials including endpoints

  • Study design consultations and data analysis

  • Medical writing for conference abstracts, publications, and more
  • Imaging charter
    development

    Our radiographic evaluation protocols (REPs) are structured as prescribed by the FDA, including:

  • Standardization of imaging modalities as well as acquisition and transfer techniques

  • Definition of parameters and analysis methods

  • Requirements and credentials of the image reviewer(s)
  • Site training &
    data management

    If needed, our dedicated clinical study experts can support with:

  • Standardization of imaging modalities as well as acquisition and transfer techniques

  • Creation of imaging-related eCRFs for central image QA/read/analysis

  • Study design and implementation support
  • Save your clinical trial time, money, and effort.

    With the help of automated image analysis and RAYLYTIC's team of experts, you can save valuable resources and win back time for your team.

    AI-powered medical image data analysis for clinical research

    RAYLYTIC is a leading developer of highly accurate AI-based algorithms for the automatic extraction of key quantitative parameters from standard clinical radiographs. 

    Possible applications in clinical research include:

    • The pre- and post-operative evaluation of musculoskeletal morphology

    • Evaluation of implant performance
    • Standardization of parameter definitions
    • Rapid analysis of large datasets, e.g. registries

    The speed and accuracy provided by these algorithms streamline radiological workflows by alleviating physicians and radiologists from subjective, time-consuming measurement tasks involved in routine care. 

    Our algorithms have been the subject of numerous scientific publications. See more below.

    Presented at

    What experts say about RAYLYTIC

    “Special, validated, computer-assisted methods, such as Functional X-ray Analysis (FXA, RAYLYTIC, GmbH), can be used to substantially increase the accuracy and precision of evaluating implant performance."

    – 1st EFORT European Consensus on Medical & Scientific Requirements for
    the Introduction of Artificial Joint Arthroplasty Devices

    Evidence-backed expertise in musculoskeletal imaging analysis

    Our clinical and scientific experts are leaders in the field of musculoskeletal image analysis who regularly partner with key opinion leaders in the field to validate our techniques and author peer-reviewed literature.

    Spine

    Can artificial intelligence support or even replace physicians in measuring sagittal balance? A validation study on preoperative and postoperative full spine images of 170 patients // read more

    Hip

    Cup positioning and its effect on polyethylene wear of vitamin E- and non-vitamin E-supplemented liners in total hip arthroplasty: Radiographic outcomes at 5-year follow-up // read more

    Methodologies to Evaluate Linear Penetration and Volumentric Wear in Clinical Studies – Imaging Techniques for the Evaluation Of Artriculations in THA, TKA to Assess Wear and Function of the Joint Throughout the Expected Implant Lifetime // read more

    Knee

    100+

    Clinical trials

    30+

    Active customers

    11

    Countries

    Validated and precise image analysis technology

    Imaging core lab services for clinical trials

    The FDA-approved Functional X-Ray Analysis software (FXA) of our imaging core lab is capable of automatically evaluating over 150 radiographic parameters of the spine, hip, or knee. The reproducibility of the measurements is on file with FDA 510(K).

    Explore some of our most popular automatically assessable quantitative radiographic parameters below.

    Range of Motion (RoM) | Radiographic parameters by RAYLYTIC

    Spine

    Range of Motion (RoM)

    The Angular Motion/Range of Motion (RoM) is a quantitative parameter used to evaluate spinal fusion.

    It is measured as the angular difference of two adjacent vertebrae during the flexion and the extension posture of a patient and is reported as an absolute value in degrees (°). RAYLYTIC’s FXA software has been shown to measure RoM 15 times more precisely than experienced physicians (Schulze et al., J Biomech 2011).

    Type

    Quantitative

    Image type

    Lateral Flex/Ex

    Unit

    Degrees (°) 

    Translational AP Motion | Radiographic parameters by RAYLYTIC

    Spine

    Translational AP Motion

    A further quantitative parameter used to assess spinal fusion, translational AP motion or instability is expressed as the difference in listhesis in flexion minus listhesis in extension. 

    Values are given in millimeters or in degrees. Positive values indicate spondylolisthesis, while negative values indicate retrolithesis.

    Type

    Quantitative

    Image type

    Lateral Flex/Ex

    Unit

    Degrees (°) or mm

    Cup Inclination and Anteversion | Radiographic parameters by RAYLYTIC

    Hip

    Cup Inclination and Anteversion

    Cup incliniation refers to the angle in degrees (°) of the cup surface against the horizontal (medio-lateral) axis. 

    Cup anteversion is the angle in degrees (°) of the cup surface against the cup symmetry axis in the frontal plane. 

    To assess these parameters, CAD models of the implants are required.

    Type

    Quantitative

    Image type

    AP Pelvis

    Unit

    Degrees (°) 

    Hip Implant Migration | Radiographic parameters by RAYLYTIC

    Hip

    Hip Implant Migration

    Migration of the hip stem relative to the femur is measured cranial-caudal (mm) and medial-lateral (mm). Angular change is measured in degrees.

    Migration of the hip cup relative to the pelvis is also meausered cranial-caudal (mm)  and medial-lateral (mm).

    Typ

    Quantitative

    Bildtyp

    Lateral Flex/Ex

    Unit

    mm

    Implant Wear | Radiographic parameters by RAYLYTIC

    Knee

    Implant wear

    Wear is a key factor affecting the lifespan of orthopedic implants and refers to the gradual erosion and subsequent production of microparticulate debris, which can cause aseptic loosening.

    In the past, quantifying wear has required additional invasive procedures. RAYLYTIC uses a validated, highly accurate 2D-3D registration technique to determine wear in standard clinical X-rays of knee replacements (Lutter et al. 2021, German Congress of Orthopaedics and Traumatology).

    Type

    Quantitative

    Image type

    AP Knee

    Unit

    mm

    Lower Limb Alignment | Radiographic parameters by RAYLYTIC

    Knee

    Lower limb alignment

    The assessment of the knee alignment using standing full-leg radiographs (FLR) is an established and standardized method for using weight-bearing radiographs to determine the load-bearing axis of the leg (Erne et al., Diagnostics 2022).

    Type

    Quantitative

    Image type

    AP Full Leg

    Unit

    Degrees (°) 

    Ready to measure radiographic parameters with the push of a button?

    Our UNITY platform makes uploading and analyzing medical images simple and quick.

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