AI-Powered Medical Image Analysis
for Clinical Trials in Orthopedics

Quantitative and qualitative assessment of implant performance

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"RAYLYTIC has created a product that encompasses all of the items I need to conduct my research at the highest quality and integrity."

Lindsay Orosz
Senior Manager Clinical Studies at Virginia Spine Institute

To support and advance both the conservative and surgical treatment of diseases and injuries of the musculoskeletal system, RAYLYTIC has developed different types of algorithms for the objective and highly precise analysis of medical images.

The image analysis module is a central component within our UNITY software, which streamlines processes related to the planning and monitoring of clinical studies.

We combine the superior precision of our image analysis with a very high degree of process automation, which leads to significant increase in efficiency as well as reduction in workload and study related costs.

Generate reliable and consistent data that meets the highest scientific requirements and facilitates submission to authorities (notified bodies, FDA, etc.) and scientific publications while fulfilling regulatory and data protection requirements.

FDA
ISO 13485
HIPAA
ISO 27001
ICH

Automated medical image analysis

Objective & reliable

One set of algorithms evaluates radiographic parameters for the quantitative and qualitative assessment of implant performance e.g., in clinical studies, post-market surveillance, IDE, registries and research.

As an experienced imaging core lab, we provide highly precise and independent analysis for over 150 radiographic parameters already predefined in our system.

We also cooperate with a network of experienced radiologists and orthopedic surgeons and can offer a full-service solution to guarantee the success of your clinical trials and research studies.

RAYLYTIC_Fusion

Selection of available parameters in our system:

Automated & validated

Another set of algorithms relieves clinicians and surgeons of tedious, time-consuming routine tasks e.g., the assessment of sagittal balance parameters or lower limb alignment angles.

These types of algorithms may facilitate or even replace manual measurements, while autonomously analyzing large datasets e.g., in nationwide registries.

presented at:
NASS
EuroSpine
DWG2
LSRS
ISASS
IMAST
Charité - Universitätsmedizin Berlin

The UNITY platform is easy to use and the collection of PROMs/CRFs is robust in daily use. The automatic anonymization of the uploaded image data and their statistical analysis are also extremely helpful.

Prof. Michael Putzier
Chief Senior Physician at the Center for Musculoskeletal Surgery/Charité Berlin
Virginia Spine Institute

RAYLYTIC has created a product that encompasses all of the items I need to conduct my research at the highest quality and integrity. Furthermore, the best part of this product is actually the customer service. I cannot express enough how impeccable the entire team at RAYLYTIC is, which ultimately makes this product even better!

Lindsay Orosz
Senior Manager Clinical Studies at Virginia Spine Institute
AESCULAP - Partner für Chirurgie

UNITY is an easy to use and intuitive application. The various dashboards give an immediate overview over the status of the running studies and makes the management of our trials easy and reportable at any time.

Marius Selig
Project Manager Clinical Studies at Aesculap/B. Braun
Emerging Implant Technologies

UNITY facilitates getting patient data and outcome measurements to a higher level. The system is easy to use, the image upload is smooth and complete data analysis is provided quickly and thoroughly, including discussions and advice for improvement.

Dr. Nancy Lamerigts
Former VP of Research and Marketing at Emerging Implant Technologies
RQMIS - Medical Device Regulatory Consulting

We have built databases for two retrospective studies including image analyses with RAYLYTIC. They helped with designing the eCRF, implemented and trained us on how to navigate the database, provided necessary documents and went above and beyond to help us achieve our goals. Working with RAYLYTIC is fantastic. The team is highly professional and extremely knowledgeable on how to run clinical retrospective studies.

DR. LAMIA BOSLI
Manager Clinical Data Management at RQMIS

UNITY ─ Your digital study nurse

Clinical Trial Management

Our flexible database design and electronic data management system can be highly individualized. To ensure the success of your trial, we also provide excellent service and support — from implementation to execution to evaluation.

  • easy study definition via drag & drop
  • dashboards with overviews of existing and missing data
  • integrated, browser-based data anonymization, transfer and storage
  • automated image selection and assignment to patient ID
  • study-specific creation of recording instructions, radiographic and data exchange protocols
  • extensive data analysis and data export functions
  • real-time validation and edit checks
  • mid-study changes to accommodate protocol amendments
  • and much more

Electronic Data Capture

Replacing error-prone, paper-based methods with an electronic data capture system boosts engagement and compliance while increasing efficiency and reducing study related costs. By enabling their precise documentation, efficient execution, real-time visualization and statistical analysis, UNITY automates and objectifies the collection of PROs and CRFs. Selected features include:

  • cross form validation and risk-based monitoring
  • integrated portfolio of questionnaires and easily definable individual questionnaires
  • configurable alerts and email notifications
  • immediate input validation and automated scoring
  • real-time reporting and graphic visualization
  • and much more

How may we support you?
Frank-Trautwein-raylytic

Frank Trautwein

frank.trautwein@raylytic.com