Wound assessment through artificial intelligence 2

Purpose and goal:

The project is in the final phase of fulfilling the objective that was set before the start of the project: to CE mark (according to MDR class IIb) and launch new AI-driven functionality within wound treatment to significantly improve the quality of care for the elderly and overall support nurses who daily work with hard-to-heal wounds.

Expected results and effects:

During the project, DermaCut AB has developed new models for AI-driven wound analysis for the treatment of difficult-to-heal wounds. The AI models have been integrated into the existing wound management software SeeWound and have subsequently been clinically evaluated with strong results. The new version of SeeWound is now in the final stages of being CE marked and launched as a medical device under MDR class IIb.

SeeWound will then be able to support medical personnel in treating leg ulcers, pressure ulcers, and diabetic foot ulcers across Europe. Approach and implementation:

The project consisted of four activities: 1) development of new AI-driven software, 2) integrate the software into existing product 3) Develop existing processes and prepare the company for certification according to ISO13485 and MDR and 4) CE mark the product according to MDR class IIb through Notified Body. The project group is satisfied that it has been able to roughly follow the schedule despite limited availability at Notified Body with strong results across activites.