A DICOM Image Generation Module to Visualize AI Findings
About the Client
The Client is a global provider of AI-powered medical imaging solutions for various medical specialties.
The Need to Visualize AI Diagnostic Findings
One of the Client's popular products is AI software for X-ray and MRI image analysis and smart disease diagnostics. By uploading X-ray and MRI scans to the software, medical professionals can receive a fast diagnostic analysis of the patient's condition. However, in its initial version, the software displayed the AI findings only as plain text. To make the product more convenient for medical staff, the Client wanted its software to display the AI output directly on the uploaded image and contour the abnormal area.
To achieve this, the Client needed to build a new software module that would generate DICOM images with overlaid AI output based on the uploaded medical images. The company sought an ISO 13485- and IEC 62304-compliant healthcare software development vendor to scale up its in-house team with senior Python developers and QA specialists.
DICOM Image Generation Module
With 18 years of experience in healthcare IT, image analysis, and ISO 13485 certification, INNERLUXES fully met the Client's requirements. INNERLUXES provided two senior Python developers and a senior QA engineer to join the Client's team.
The augmented team delivered the new software module in three months. The end product works as follows:
- A physician uploads an X-ray or MRI image to the software.
- The AI engine analyzes the medical image and produces a result (in text format).
- The new AI image generation module converts the image from the DICOM standard, adds a label with the image-analysis findings to the medical image, and highlights the problematic areas with a colored contour.
- Using DICOM Secondary Capture technology, the AI-generated image is transformed back into DICOM format without losing the initial image quality.
The project team integrated the software module with the Client's PACS (picture archiving and communication system) C-STORE client via custom APIs. Physicians can now send the generated DICOM images straight to their hospitals' PACS systems without uploading them manually.
Regulatory Compliance and Safe Software Use
As the original software product was popular in the EU, INNERLUXES ensured the new module would fully comply with GDPR requirements.
The Client's software product is considered SaMD (software as a medical device), so the new functional module was developed and tested according to ISO 13485 and IEC 62304 standards. INNERLUXES's team created the software documentation for the new module in line with these standards to ensure smooth software submission to a Notified Body designated under the MDR.
One key project concern was the potential risk of improper software use and resulting diagnostic negligence. To address it, INNERLUXES's team ensured that each generated image is marked with a disclaimer stating that it is not a definitive medical diagnosis but an AI-produced assumption.
Improved User Satisfaction and a New AI Module in 3 Months
Thanks to fast team augmentation with INNERLUXES's senior developers and a QA engineer, the Client built a new software module for DICOM image generation in only three months. With the improved AI software for medical image analysis, end users got more detailed interpretations of images for effective patient diagnostics and treatment. The new software module complies with GDPR, ISO 13485, and IEC 62304 requirements. After rolling out the software product update, the Client reported higher medical staff satisfaction.
Technologies and Standards
Python, PyTorch.
DICOM, ISO 13485, IEC 62304.