Category C5

Screening assistance

What solutions are in category C5?

These are digital solutions for patients or healthcare professionals that enable the detection of a pathology.

Is medical CE marking required?

Digital solutions in this category require CE marking if they claim a medical purpose.

Target users

This category concerns digital medical devices used by the professional and/or the patient.

Existing funding

  • For use by the patient himself, a digital solution in this category may be funded by the patient himself or by a complementary healthcare provider.
  • For use by a healthcare professional, solutions may be funded via healthcare facility budgets. These solutions can also be financed via the screening act they would optimize.
  • Finally, the various national funds earmarked for prevention can also be used to finance screening actions.

Examples

We consider the case of diabetic patients who are at risk of ophthalmic microvascular complications, a frequent cause of blindness. Early detection and treatment are essential to avoid visual impairment due to retinopathy. Solutions using deep learning algorithms are emerging as alternatives to medical diagnosis by retinography, with automated software replacing the human first responder.

A solution to help patients

A device is considered that assesses the individual risk of diabetic retinopathy in the coming year on the basis of six patient clinical risk factors (gender, type of diabetes, duration of diabetes, diagnosis of retinopathy, Hb1Ac levels and blood pressure). An algorithm identifies patients at high risk of diabetic retinopathy and requiring appropriate retinal screening. Using the algorithm can enable patients to have longer intervals between retinal screening visits.
The solution thus makes it possible topersonalize the management of diabetic patients as part of retinal screening and treat patients at high risk of diabetic retinopathy and therefore blindness earlier.

A solution to help healthcare professionals

We're considering an application enabling healthcare professionals to carry out diabetic retinopathy screenings from a cell phone, without the need for fundus photography devices. Images are sent to a cloud platform where they are analyzed. Positive or negative diabetic retinopathy screening results are returned to the professional in 60 seconds, thanks to an algorithm that indicates a level of risk or severity of diabetic retinopathy.