IT'S HERE: Download our latest checklist "What to consider when choosing a patient/device registry software"
Imaging expertise. Meaningful data delivered.
Imaging core lab services
At RAYLYTIC’s imaging core lab, we offer automated imaging analysis in clinical trials. Our goal: Streamlining imaging in orthopedic clinical trials to provide MedTechs, CROs, and hospitals with consistent radiographic outcome data and reliable results.
Offering medical device trials the complete spectrum of core lab imaging solutions
Over 30 implant manufacturers of all sizes have achieved success using RAYLYTIC’s end-to-end imaging core lab services across various regulatory pathways, including IDE, 510(k), CE-marking, and PMCF.
Automated
image analysis
Radiologist
Network
Imaging data
management software
Scientific
consultations & medical writing
Imaging charter
development
Site training &
data management
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.
Accelerate your clinical trial with AI-powered medical image analysis
RAYLYTIC is a leading developer of highly precise, AI-powered image analysis applications for clinical trials.
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
Core lab capabilities
How our imaging core lab helps streamline medical device clinical trials
Our imaging core lab empowers orthopedic and spinal device developers to maximize their impact through advanced automated medical image analysis and deep expertise in the scientific, regulatory, and therapeutic landscape. By leveraging precise, objective imaging, we help showcase the unique biomechanical and clinical advantages of orthopedic and spinal devices, ensuring data-driven insights that support innovation and compliance
Imaging modality expertise
X-ray
CT
MRI
Spine Imaging Endpoints
- Range of Motion (RoM)
- Center of Rotation (CoR)
- Disc height
- Anteroposterior instability
- Cobb Angles
- Cervical & Lumbar Lordosis
- And over 100 other radiographic outcome measurements
Knee Imaging Endpoints
- Implant component postioning
- Implant component alignment
- Femoral-Tibia Angle
- Joint line conversion angle
- Distal Tibia Angle
- Proximal femur angle
- And more
Hip Imaging Endpoints
- Cup anteversion
- Cup inclination
- Pelvic obliquity
- Leg length difference
- Caput-Collum-Diaphyseal Angle
- Femoral offset
- And more
Evidence-backed expertise in musculoskeletal imaging analysis for clinical trials
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
RAYLYTIC Imaging Core Lab Capabilities
Medical imaging analysis for clinical trials in orthopedics and spine
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.
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 (°)
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
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
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
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
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 (°)