About the Customer
Headquartered in Linköping, Sweden, SyntheticMR is a pioneer in developing cutting-edge software solutions for Magnetic Resonance Imaging (MRI) that enable quicker and more precise diagnosis of patients worldwide. Through a single 6-minute acquisition, the company’s flagship solutions SyMRI MSK and SyMRI Neuro runs on a wide range of anatomies to provide quantitative contrast-weighted images such as TE, TR, T1W, T2W, PDW and STIR. Both solutions therefore focus on supporting a faster MR imaging workflow at hospitals and allow doctors to follow disease progression and therapy efficacy with higher confidence.
The Pain Point
SyntheticMR wanted to conduct a validation study to compare the image quality in SyMRI on knee and spine with conventional images. The findings from the study were to be used in an FDA-submission and for regulatory clearance in Europe and other regions of their SyMRI MSK solution.
They had specific objectives to be accomplished in an organized and efficient manner including:
- Determining non-inferior image quality in SyMRI compared to conventional images for knee and spine
- Evaluating eligibility of anatomical structures in synthetic images compared to conventional images
- Determining comparable radiological findings in synthetic and conventional images
The answers populated from the study were to be summarized on group level and used to draw statistical conclusions based on the objectives for the study.
With prior extensive experience filing for FDA approvals for their SyMRI Neuro, they were aware of the hurdles to expect. They wanted to fast track the process of curating all resources necessary to execute the validation studies for filing the FDA approval for SyMRI MSK.
Synthetic MRI wanted a single platform to engage clinical experts from across different countries and provide their feedback on the image quality, morphological legibility as well as radiological interpretation of the case. They were aiming to execute this process in a timely and efficient manner without extensive groundwork needed by domain experts.
The CARPL platform, therefore, served as a single window platform that enabled implementation of a qualitative validation study comparing conventional and SyMRI images. The platform brought together retrospective data and over ten experienced radiologists from the USA, Europe and India for smooth study execution. It supported seamless reading experience for the experts by offering following unique features–
- No local software download or installation was required
- CARPLs built in DICOM viewer with functionality for pan, window, zoom, image annotations was used
- Ability to access images in an online teleradiology platform with all cases available on login
- Readers could provide feedback and answers directly on the platform, without filling in a separate excel form
CARPL’s one-of-a-kind retrospective data curation, reading and annotation tools, helped Synthetic MR significantly reduce the study execution timeline from several months to a single month.