Project Started in 2017
The work conducted by Innolitics to complete a complex software port of a core module of our clinical product was outstanding. The clinical product must by cleared by the FDA, and as such, we needed the highest quality workmanship, and close collaboration with a dispersed team. Innolitics performed exceedingly well in gathering requirements, researching, developing and implementing a design, and providing test modules and documentation. Their team's understanding of medical imaging analysis software, and FDA quality processes, was key to the success of the project.
The AutoRegister project is:
A software-based system for an MRI scanner to reduce the error in tumor measurement. -CorticoMetrics
MRI assessments are extremely sensitive to the subject’s position inside the machine. This sensitivity can be mitigated by using image data from the subject’s previous MRI sessions. AutoRegister aligns acquired imaging data to previous data from the same subject to improve the accuracy of tumor growth detection with an MRI.
CorticoMetrics developed a working prototype of this software but needed a partner to bring it to market. The company hired us because of our experience in medical imaging, especially with DICOM, image registration, and IEC 62304. Our engineers were able to re-implement their prototype and get it ready for a 510(k).
The engineer at CorticoMetrics was not familiar with integrating software into an MRI machine and hospital PACS. We were contracted to get AutoRegister integrated with these systems. By hiring us, CorticoMetrics was able to integrate its product into industry testing quicker than if they were to rely only on in-house engineers.
Reserving a time to use an MRI in a hospital can be costly and hard to acquire due to busy hospital schedules. In order to make the most use of their MRI appointments, CorticoMetrics needed to be able to make on-site adjustments to the software during testing. Our team ensured the engineer on staff was familiar with the configuration of AutoRegister to the Hospital IT so he could make the most use of his time testing the software.
CorticoMetrics needed a way to test AutoRegister without having to buy an MRI machine. To solve this issue, we developed an MRI emulator to test AutoRegister as if it were integrated with an MRI machine.
In order to get AutoRegister approved by the FDA, CorticoMetrics needed to ensure the product was tested. Our team delivered integrated tests to ensure the product was ready for FDA approval.
Submitting a 510(k) for a product requires documentation. Our team provided thorough documentation for our services, delivering software that is suited for 510(k) review.
After completing our contract for the AutoRegister product, the prototype of the software was rewritten, validated, documented, and they were on track to submit their first 510(k). In all, we brought more robustness to the software team at CorticoMetrics and helped them expedite the process to bring their product to the market.