Products from RAYLYTIC

RAYLYTIC develops software that is used to support automated medical image analysis and predictive health analytics in clinical trials and precision medicine.​
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Our flagship product, UNITY, is an AI-enabled SaaS platform that integrates with EHR and PACS systems to support large-scale process automation and data analytics tasks.

RAYLYTIC has been supporting big, medium and small MedTechs in the US and Europe for more than 20 years.​ We have assisted with data collection and analysis services in over 100 studies: IDEs, 510(k)s, CE, post-market and research studies. Our customers also use UNITY to host several clinical registries.

Data collected with the UNTIY platform, as well as the analyses and radiographic protocols generated by the RAYLYTIC team, are frequently submitted to regulatory bodies such as the FDA.

Currently, our customers are running 33 studies – including 3 spine IDEs – using the UNITY platform.

UNITY is an AI-enabled SaaS platform for the collection and management of clinical data that can be used in different types of clinical trials e.g., IDEs, 510(k)s, CE, post-market and research studies as well as registries.​

UNITY consists of three main modules: an EDC system, a CTMS and an integrated DICOM image manager with upload and transfer capabilities.​

The platform is designed to automate manual processes and streamline communication between stakeholders to help accelerate trial outcomes and improve clinic workflows.

Our UNITY platform streamlines processes and communication between stakeholders by automating manual tasks, for example the management and monitoring of queries and adverse events.​

The integrated image upload and storage in combination with our Imaging core lab services, adds significant value as the time needed for the related workflows is significantly reduced.

All stakeholders − patients, clinic staff, study sponsors as well as a network of independent radiologist in case of qualitative assessment needs − access and communicate via the same platform − each with their specific user rights setting.​

Study overviews and dashboards, interactive reports, email alerts, medical coding, are some additional features that accelerate trials conducted with UNITY.

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Yes. Our UNITY platform can be and is used in multicenter trials around the globe.​ It is web-based and therefore requires no installation and does not include any hardware. ​Therefor it can be accessed from anywhere in the world at any time of the day.

As we handle highly sensitive data, data security is of utmost importance to us.​ The UNITY platform is 21 CFR Part 11, GCP and HIPPA compliant. Our data storage is ISO 27001-certified and we, of course, do have an ISO 13485-certified quality management system.​

In addition, we are regularly audited by notified bodies as well as clients during vendor approvals.

Our imaging core lab delivers independent and highly automated medical image analysis and operational support for clinical research.​

We currently offer to analyze over 150 qualitative and quantitative parameters in musculoskeletal morphology and implant performance, for example fusion, prosthetic wear, device migration or subsidence. ​

As component of our imaging core lab services our team offers support during all steps − from initial endpoint designs to wrap-up data interpretations for publications and regulatory submissions.

Currently, our image analysis capabilities and developments are targeted to musculoskeletal diseases. Expansion into other therapeutic areas are indeed planned in the future.​

However, our existing image transfer and storage services can be and are already used in clinical trials outside of orthopedics, for example in cardiovascular studies.

Images − X-rays, CTs and MRIs − are transferred to us securely directly via the UNITY platform. Files are dragged and then dropped into our integrated DICOM viewer.​

Before files are uploaded to our server, they are automatically classified, quality controlled and deidentified.​ The image classification prevents that, for example, a long leg image is uploaded to a spine study.

Furthermore, images are automatically saved according to their respective timepoint within the study thereby eliminating having to manually name and organize the files.

Patients have four different options for completing ePROs (electronic patient reported outcomes) in the UNITY platform:

• Patient information can, of course, be collected using paper forms. Site users can then manually enter the data. Manual data entry can pose certain risks to data integrity, so there are three alternative electronic options for capturing patient-reported data.
• Patients can also enter data via tablet while in the waiting room. The collected data is automatically transferred.
• For elderly patients, UNITY’s so-called “Interview mode” may be more appropriate. Here, the attending physician or a nurse goes through the questionnaire with the patient in a personal conversation and fills them out on the computer or tablet himself.
• With the consent of the patient, it is also possible to answer questionnaires from home. In this case, questionnaires are sent via mail directly to the patient. Beneficial for patients is here, that they can answer their questions from anywhere and at any time.