AITIS’ Skin Cancer and Wound Care Apps Now EUDAMED Approved

We are thrilled to announce that AITIS’ Skin Cancer App and Wound Care App have officially received EUDAMED approval, marking a significant milestone in our mission to deliver safe and effective digital health solutions.

What is EUDAMED?

EUDAMED (European Database on Medical Devices) is the European Union’s centralized database designed to enhance transparency and traceability of medical devices and software. Managed under the EU Medical Device Regulation (MDR), EUDAMED stores essential information about device registration, clinical investigations, safety monitoring and market surveillance.

Why This Approval Matters

Receiving EUDAMED approval confirms that our apps meet the highest European standards for safety, quality and regulatory compliance. This achievement strengthens trust in our solutions among healthcare professionals and patients, while also enabling broader access to the EU market. It highlights Aitis’ commitment to innovation and to developing digital health tools that are both reliable and effective.

With this approval, Aitis is well-positioned to expand the reach of our apps across Europe, supporting clinicians and patients with AI-driven solutions that improve patient outcomes and advance the landscape of digital healthcare.