Category C6

Diagnostic assistance

What solutions are category C6?

These are digital medical devices making proposals for diagnosis of a pathology or health condition or prognostic information available to the healthcare professional.

Is medical CE marking required?

These digital solutions must be medical CE marked, and may rely on other physical medical devices for the measurement or collection of useful health data.

Target users

This category mainly includes digital solutions aimed at the healthcare professional. These are digital medical devices that can also collect and transmit patient data and be used by the patient with the aim of enabling the healthcare professional to make a diagnosis.

Existing funding

Depending on whether the diagnostic aid solution is used by healthcare professionals in a city or hospital setting, the funding model differs.

  • For in-town use: certain medical devices may be financed via the structure package. They may also be financed viathe diagnostic act optimized by the digital solution.
  • For hospital use: digital devices in this category may be financed via healthcare facility budgets.

Example

Generic software solution for tumor detection using imaging techniques

We're considering software for tumor detection using imaging techniques in the field of anatomopathology. It uses artificial intelligence to analyze images from different medical imaging modalities (MRI, CT, etc.) to automatically detect and characterize tumors.
The main features include:

  1. Automatic image analysis to locate suspicious areas;
  2. Precise segmentation of tumor contours;
  3. Characterization of tumor type (benign/malignant);
  4. Measurement of lesion volume and dimensions;
  5. Comparison with a database of similar cases.

This software uses deep learning algorithms trained on large databases of annotated medical images. The software can analyze an image in seconds and provide a detailed report to the pathologist. The benefits of using this software include:

  • Early detection of tumors that are difficult to spot visually;
  • Saving time for radiologists and pathologists;
  • Aiding diagnosis and lesion characterization;
  • Accurate tracking of tumor evolution over time.

This type of diagnostic aid software makes it possible to improve the accuracy and speed of tumor detection, while assisting physicians in their decision-making.