Software DevelopmentFast 510(k)Regulatory StrategyFDA Hold Letter ResponseWeb-AppImage ProcessingDICOM510k
Testimonial
Working with Innolitics has been a fantastic experience. Their technical and regulatory expertise is exceptional—it's not just programming; it's science combined with a deep understanding of FDA regulations. Interacting with their team feels like collaborating with fellow scientists who navigate the complexities of regulatory compliance effortlessly. Their mastery in detailing the ends of the slice ranges (they'll know what I mean) and guiding us through the FDA process has been impressive. I've recommended them multiple times and will continue to do so.
Tim Szczykutowicz, PhD
CEO
The Problem
In radiology, the variability in imaging parameters across different CT scanners and clinical sites leads to inconsistent image presentations. This inconsistency forces radiologists to adapt to varying image qualities and presentations, potentially leading to inefficiencies, fatigue, and challenges in accurate diagnosis. The solution aims to standardize image presentation, streamline workflow, and enhance radiologists' efficiency.
What We Did
Together with the RadUnity team, we developed a software medical device designed to aid in the management and processing of CT images. We also prepared the FDA 510(k) submission, performed software validation, and implemented cybersecurity controls necessary for a successful 510(k).
Key Accomplishments
Built a data-intensive web application capable of:
Sending/receiving DICOM CT images
Automatically mapping DICOM metadata to pre-configured image-processing configurations
Performing image processing jobs on DICOM image data (to reorient, reslice, and resample images)
Presenting processing status and user configurations in a modern web UI dashboard
Completed the full software engineering lifecycle and achieved 510(k) clearance within 14 months.
Clinicians are shown a dashboard, displaying the status of received
DICOM data, and allowing them to take any needed actions.
Administrative users configure “mappings” that are used to automatically
link DICOM data received by the application with a “profile” of image
processing configurations. E.g., a Chest CT might be configured to
automatically produce axial and coronal views with certain desired slice
thicknesses.
A user can select a subset of the extent of a CT scan to be processed
using sliders in a coronal view (shown in the center). Previews in the
axial plane for the endpoints of the selected extent and midpoint are
displayed (shown on the right).
Key Technologies
A modern React-based web UI
A Python-based web server
A Python-based image-processing server
An Orthanc-based DICOM sender/receiver
Timeline
October 31, 2023: Scoping and strategy complete
November 30, 2023: Presubmission meeting
February 4, 2024: Backend implementation complete
May 1, 2024: Frontend implementation complete
September 18, 2024: 510(k) Submitted
November 26, 2024: 510(k) Cleared!
Let's Talk
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