AI Medical Technology
AI Medical Technology
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What is AI Medical Technology?
AI Medical Technology Dermalyser is a CE-marked AI-powered mobile application that provides decision support for healthcare professionals assessing suspected skin melanomas. The app analyzes dermatoscopic images captured with a smartphone and dermatoscope, delivering results in just 5 seconds. It serves as a 'second set of eyes' for clinicians, helping them make faster, more accurate diagnoses while reducing unnecessary referrals and healthcare costs.
AI Medical Technology pricing
Pricing model: Freemium
Dermalyser requires a clinic license obtained by the clinic director or person responsible for medical device procurement. Specific pricing details are not publicly listed on the website; interested users must book a demo to receive pricing information. The website mentions 56% cost savings through reduced time per patient and no need for external expert second opinions, but does not disclose subscription fees, per-use costs, or tiered plan options.
AI Medical Technology pros
- CE-marked medical device software (Class IIa, MDR EU 2017/745)
- 96% AUC accuracy in skin lesion diagnostics
- 95.2% sensitivity for all melanomas, 100% for invasive melanomas
- 99.5% negative predictive value for ruling out malignancy
- 5-second analysis with immediate feedback during consultation
- 56% cost savings from less time per patient
- 79% fewer referrals due to more accurate assessments
- Works with smartphone and compatible dermatoscope
- Clinically validated with over 100,000 skin lesion images in database
- GDPR-compliant with pseudonymized data storage in EU-based cloud
- Data encrypted during storage and transfer
- Digital training, manuals, and customer support included
- Onboarding assistance with installation and staff training
- Outperforms general practitioners (96% vs 70% AUC)
- Final diagnosis decision always remains with the doctor
AI Medical Technology cons
- Only for licensed healthcare professionals, not available to patients
- Requires purchase of compatible dermatoscope separately
- Validated only for Fitzpatrick skin types I–IV, not darker skin
- Cannot be used on patients under 18 years of age
- Cannot analyze ulcerated or open skin lesions
- Cannot analyze lesions smaller than 2mm or larger than 2cm
- Cannot be used on mucous membranes, under nails, palms, soles, or near eyes
- Cannot be used on tattooed skin or already biopsied lesions
- Does not replace medical expertise, only provides decision support
- License must be obtained by clinic director, not individual doctors
Frequently asked questions about AI Medical Technology
What is Dermalyser?
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, providing AI-driven results in seconds.
Who can use Dermalyser?
Only licensed healthcare professionals, such as general practitioners, primary care physicians, and dermatologists. It is not available for use by patients or unlicensed individuals.
Does Dermalyser replace the doctor's diagnosis?
No. Dermalyser is a decision-support tool. The final diagnosis is always made by healthcare professionals. The AI provides assistance but the doctor has the final word in diagnosis.
What equipment is needed to use Dermalyser?
A smartphone with the Dermalyser app, a compatible dermatoscope, and a clinical environment with trained healthcare staff are required to use the tool effectively.
What skin types is Dermalyser validated for?
Dermalyser has been validated for patients with Fitzpatrick skin types I–IV. It has not been validated for darker skin types (V–VI).
What are the clinical performance results?
Clinical validation studies show 96% AUC for all melanomas and 98.8% AUC for invasive melanomas, with 95.2% sensitivity and 84.5% specificity for all melanomas, and 100% sensitivity and 92.6% specificity for invasive melanomas.
Is Dermalyser CE-marked?
Yes. Dermalyser is CE-marked under MDR (EU) 2017/745 as medical device software, Class IIa. Relevant regulatory information such as UDI and notified body details is made available where appropriate.
How is patient data handled and stored?
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 with all storage and transfer encrypted.
How do I get started with Dermalyser at my clinic?
To start using Dermalyser, your clinic must first obtain a license, typically decided by the clinic director or person responsible for medical device procurement. Once the license is in place, the company assists with onboarding including installation, staff training, and ongoing support for smooth integration into clinical practice.
What are the limitations and warnings for using Dermalyser?
Dermalyser must not be used on patients under 18, ulcerated or open lesions, lesions smaller than 2mm or larger than 2cm, mucous membranes, under nails, on palms or soles, near the eyes, on tattooed skin, or on lesions already biopsied. Clinical judgment always takes precedence as the tool is decision-support only.