Dermalyser is a CE-marked software that uses artificial intelligence to analyze digital dermatoscopic images of skin lesions. It functions as a decision-support tool for healthcare professionals when assessing suspected skin melanomas.

Only licenced healthcare professionals, such as general practitioners, primary care physicians, and dermatologists.

No. Dermalyser is a decision-support tool. The final diagnosis is always made by healthcare professionals.

A smartphone with the Dermalyser app, a compatible dermatoscope, and a clinical environment with trained healthcare staff.

Dermalyser has been validated for patients with Fitzpatrick skin types I–IV.

No. Dermalyser is intended for suspected melanomas. It should not be used on ulcerated or open lesions, very large lesions, lesions on mucous membranes, under nails, on palms or soles, near the eyes, or on lesions that have already been biopsied.

An analysis typically takes only a few seconds once the image is captured.

Clinical validation studies show high accuracy for all melanomas (AUC 0.96) and even higher for invasive melanomas (AUC 0.988), with very good sensitivity (95.2% and 100%, respectively) and specificity (84.5% and 92.6%, respectively). https://doi.org/10.1093/bjd/ljae021

Yes. Dermalyser is continuously monitored in clinical practice to ensure safety and performance, in line with regulatory requirements.

Yes. Dermalyser is CE-marked under MDR (EU) 2017/745 as medical device software, Class IIa.

Yes. Relevant regulatory information, such as UDI and notified body details, is made available where appropriate.

All personal data is handled in accordance with GDPR. Images and metadata are pseudonymized and cannot be linked to a patient without complementary information from the clinic's medical record system.

For European users, data is stored in highly secure, EU-based cloud services. All data storage and transfer are encrypted.

Only in anonymized form, and only after ethical approval, informed consent, and according to data management agreements.

To start using Dermalyser, your clinic must first obtain a license. This decision is typically made by the clinic director or the person responsible for medical device procurement.

Yes. We provide digital training, manuals, and customer support with clearly defined service levels. Once the license is in place, we assist with onboarding – including installation, staff training, and ongoing support – so that you can integrate Dermalyser smoothly and efficiently into everyday clinical practice.

Dermalyser must not be used on patients under 18 years of age, on ulcerated or open skin lesions, lesions smaller than 2 mm or larger than 2 cm, on mucous membranes, under nails, on palms or soles, near the eyes, on tattooed skin, or on lesions that have already been biopsied. In case of any uncertainty regarding the correct use of Dermalyser, always consult the instructions for use for full information.

The clinical judgment always takes precedence. Dermalyser is a decision-support tool and does not replace medical expertise.