SkinVision

by SkinVision  · Based in Netherlands → — Making Skin Health More Accessible
Dermatology

Paid
Regulatory Status Disclosed

Overview

SkinVision is a health technology company based in Europe, dedicated to increasing access to skin health awareness and care through its AI-powered smartphone application. The tool is designed to empower individuals to take a more active role in monitoring their skin over time, providing an initial assessment of skin cancer risk factors and guiding users on when to seek professional medical advice.

The core functionality of the SkinVision app involves users taking photos of moles or suspicious skin lesions. Leveraging advanced artificial intelligence, the app analyzes these images to evaluate potential risk factors. This AI-driven assessment helps users identify changes or characteristics that warrant further attention from a dermatologist, facilitating earlier detection of potential skin cancers, including melanoma.

While primarily a direct-to-consumer application, SkinVision aims to integrate with broader healthcare systems, supporting physicians by streamlining patient referrals and providing a preliminary layer of screening. The company emphasizes a commitment to responsible innovation, collaborating with medical experts, researchers, and institutions like Mayo Clinic to advance its digital health solutions and ensure adherence to regulatory requirements in all markets it serves.

Currently, SkinVision is widely available in Europe and other regions, often covered by health insurers. Its launch in the United States is planned, pending applicable regulatory clearance from the FDA, underscoring its dedication to meeting stringent health technology standards globally.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered skin cancer risk assessment
  • Mole tracking and monitoring over time
  • Personalized advice on seeking professional care
  • Educational content on skin health
  • Dermatologist-reviewed results (in some regions/plans)

Use Cases

  • Early detection of suspicious skin lesions
  • Self-monitoring for individuals at risk
  • Supporting timely referral to dermatologists
  • Empowering patients in their skin health journey

What Physicians Need to Know

Key Capabilities
AI-powered risk indication for common skin cancers (Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Actinic Keratosis) from smartphone photos. Combines AI with dermatologist expertise for assessment. Features include body mapping for tracking changes, personalized skin advice, and PDF report generation for sharing with healthcare professionals. It provides a risk indication, not a diagnosis, and recommends further action.
Clinical Utility
Aids in early detection of skin cancer, potentially improving patient outcomes and reducing treatment costs. Supports digital triage in primary and secondary care, enhancing referral quality and potentially reducing unnecessary consultations. Helps alleviate pressure on healthcare systems and waiting lists by digitizing routine skin checks. Can serve as a supplementary tool for physicians for a second opinion or initial risk assessment.
Integration Options
While direct EMR/EHR integrations are not extensively detailed, SkinVision allows users to generate PDF reports of scans, which can be shared with healthcare professionals. The company has explored integrating its technology into healthcare systems and offers a 'SkinVision Pro' platform for specialists to provide online monitoring services.
Compliance Status
CE-certified medical device app (EU MDR Class IIa), representing the highest medical device standard for safety and reliability in the EU. Adheres to international risk management standards (ISO 14971) and employs certified quality and security systems (ISO 13485 and ISO 27001). Currently undergoing a pivotal trial with Mayo Clinic to support FDA clearance in the U.S. Development has addressed HIPAA and GDPR compliance.
Pricing Model
SkinVision is a premium, paid-for medical service, offering flexible plans. Access may be free or discounted through partnerships with health insurers and other programs. Historically, a 'SkinVision Pro' platform offered an annual subscription for specialists.
User Experience
Designed for ease of use and an intuitive interface, with high user ratings (over 4.5 stars on average). Provides rapid AI-based risk assessments within seconds, with more complex cases reviewed by dermatologists within 40 hours. Some studies indicate varying levels of confidence among dermatologists regarding smartphone apps for melanoma detection, though the role of digital triage is recognized.
Support Quality
Supported by an advanced quality system involving dermatologists globally. Customer support is available via email for inquiries and refunds. The company emphasizes a human element, stating 'real people are behind the app'.
Implementation Complexity
As a mobile app, it offers relatively low complexity for individual user adoption. For healthcare systems, integration into existing workflows and addressing physician perceptions regarding AI accuracy are key considerations. Development challenges included ensuring image quality, data security, and navigating regulatory approvals.
Evidence Base
Clinically validated and deemed safe and reliable, with a strong scientific foundation from collaborations like Erasmus MC. Multiple studies on diagnostic accuracy exist, with recent research claiming sensitivity of 95.1% and specificity of 78-89% for detecting common skin cancers. However, some studies suggest these figures might be overestimated due to study design. One study noted a higher false positive rate compared to dermatologists. The algorithm is continuously updated and validated with extensive image data and dermatologist input. A pivotal trial is underway with Mayo Clinic to generate further clinical evidence for U.S. regulatory approval.
Physician Tip

SkinVision serves as a valuable pre-screening and monitoring tool, particularly for patient self-assessment and triage. While its high sensitivity for detecting common skin cancers is promising, be mindful of potential false positives that may lead to unnecessary referrals. Always emphasize to patients that the app provides a risk indication, not a definitive diagnosis, and does not replace professional medical evaluation. Encourage patients to utilize the PDF report feature to facilitate discussions during consultations. For darker skin types (IV, V, and VI), be aware of potential camera limitations affecting AI analysis.

Currently, direct, seamless EMR/EHR integration for automated data flow may be limited. Healthcare professionals can leverage the app's PDF report generation to incorporate patient-provided information into their records. Explore potential partnerships with SkinVision or health insurers in your region, as these can offer structured pathways for integrating the tool into care pathways and potentially provide access for your patient population. The 'SkinVision Pro' platform suggests a framework for professional engagement, which may evolve to include more robust integration capabilities.

Details

Category Dermatology AI, Patient Engagement & Education
Pricing Paid
  • SkinVision offers flexible plans, including single checks (€10–25) and annual subscriptions (€50–100)
  • It also provides 3-month or yearly plans
  • Some features, such as risk profile, skin type quizzes, image storage, and UV information, are available for free
  • The service can also be free or discounted through partner programs, including health insurers
Free TrialUnknown
DeploymentMobile App
Mobile AppTrue
Data ExportUnknown
LanguagesEnglish, Dutch, German, French, Spanish, Italian, Portuguese, Swedish, Norwegian, Danish, Finnish
TrainingUnknown
Target SizeIndividuals, also offered through insurance companies and employers/organizations.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant No AI-estimated
FDA Status False AI-estimated

SkinVision is not yet available in the United States, with U.S. availability subject to FDA authorization. The company is currently collaborating with Mayo Clinic on a pivotal trial required by the U.S. Food and Drug Administration (FDA) to support its U.S. regulatory pathway.

GDPRUnknown AI-estimated
Integrations
EHR Not specified
Specialties Dermatology

Social Proof

CustomersOver 3 million users worldwide.
Notable
Partnerships with health insurers such as CZNationale Nederlandenand Zilveren Kruis in the NetherlandsMedicash in the UKand Accuro in New Zealand. SkinVision also has a research collaboration with Mayo Clinic.

Support & Reliability

Training ProvidedUnknown

What the Web Says

SkinVision is a mobile application that utilizes artificial intelligence and machine learning to assess the risk of skin lesions from user-submitted photos, providing a risk rating (low, medium, or high) and recommending whether to seek medical attention. While it aims to facilitate early detection of skin cancer and increase awareness, its diagnostic accuracy has been a subject of debate among medical professionals and reviewers.

Overall: Mixed

Strengths

  • User-friendly and easy to operate, allowing for quick assessment of skin lesions.
  • Can provide peace of mind for users with low-risk results and prompt those with high-risk lesions to seek timely medical attention.
  • Offers reminders for re-assessing spots, which is helpful for monitoring changes over time.
  • Backed by some studies reporting high sensitivity for detecting malignant or premalignant lesions.
  • Can help reduce unnecessary referrals to dermatologists, allowing healthcare professionals to focus on more critical cases.
  • Some users have reported successful early diagnosis and treatment of skin cancer after using the app.

Limitations

  • Concerns from physicians and systematic reviews regarding its diagnostic accuracy, particularly when verified against expert dermatologist recommendations.
  • High rate of false positives, potentially leading to unnecessary anxiety and dermatology visits.
  • Studies evaluating the app's accuracy often have methodological weaknesses, such as small sample sizes and images captured by clinicians rather than actual users.
  • Not a diagnostic tool and should not replace a professional medical diagnosis.
  • Difficulty in capturing clear images of certain body parts, and the front camera is not supported for quality reasons.
  • Some experts criticize that the reported high sensitivity and specificity in certain studies might be overestimated due to study design and sampling errors.

Based on reviews from: PubMed, AJMC, The BMJ, Healio, The Medical Futurist, PMC, Apple App Store, Future Wellness & Tech, Reddit, Beauty Tech Derm, The Guardian, Trustpilot, Live Forever Club, Google Play Store, Facebook

Last updated: 2026-08-11

Ratings & Reviews

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Ease of Use
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Press & Coverage

PR Newswire UK
SkinVision Pro Launches Globally at HLTH Europe: AI-powered Skin Health Platform Connected To Healthcare Providers
SkinVision launched SkinVision Pro at HLTH Europe, a platform connecting AI-powered skin health assessments directly to medical practices, providing doctors with structured information before consultations. The SkinVision Service is a CE-marked Class IIa medical device with clinically validated accuracy of over 90% sensitivity and 89% specificity for skin cancer detection.
2026-06
SkinVision (Press Release)
SkinVision Collaborates on Pivotal Trial to Improve Access to Dermatology Care in the United States
SkinVision announced a research collaboration with Mayo Clinic to conduct a pivotal trial required by the U.S. Food and Drug Administration (FDA) to support the company's U.S. regulatory pathway. This collaboration aims to generate robust clinical evidence for FDA clearance and validate the technology within the U.S. population.
2026-03
Rabobank
SkinVision helps reduce healthcare waiting lists with AI-powered skin cancer checks
SkinVision, a Dutch health tech company, is expanding its international growth with support from Rabobank, focusing on the US healthcare market. The AI-driven app helps millions worldwide with early skin cancer detection, aiming to reduce deaths by 50%.
2026-04
SkinVision (Press Release)
SkinVision Earns Europe's Top Medical Certification for AI-Powered Skin Cancer Detection
SkinVision was the first AI-powered medical device to receive CE registration under the EU Medical Device Directive (MDD) and has now achieved the higher Class IIa certification under the EU Medical Device Regulation (MDR). This certification applies to all medical devices in the EU and sets a new standard for safe, AI-powered health tools.
2025-08
Beauty Tech Derm
Can AI Really Detect Skin Cancer? A Deep Dive into SkinVision
This article explores the accuracy of the SkinVision app, noting its algorithm has a reported sensitivity of 95% for detecting skin cancer, but emphasizes it is a risk assessment tool, not a diagnostic one. It highlights the pros of being fast, easy, and accessible, while also mentioning cons like not replacing a full-body check and potential false positives.
2025-06
Checkmole
Are AI Mole-Checking Apps Like SkinVision Actually Accurate? What the Research Shows
This article reviews the accuracy of AI mole-checking apps, focusing on SkinVision, and notes that while peer-reviewed research shows meaningful sensitivity for detecting malignant lesions, other independent research indicates it may over-flag harmless moles. It also clarifies that SkinVision holds a CE mark as an EU MDR Class IIa medical device, which is different from FDA clearance in the United States.
2026-08
Journal of the European Academy of Dermatology and Venereology (JEADV)
Sensitivity and specificity of SkinVision are likely to have been overestimated
This article discusses concerns that the reported sensitivity (95.1%) and specificity (78.3%) of the SkinVision app may have been overestimated due to study design and sampling errors. It aims to assess the diagnostic accuracy of the CE-certified app in a real-world setting.
2026-05
Dermatology Times
Digital App Successfully Detects Skin Cancers
A study involving over 2.2 million customers of a Dutch insurance company in 2019 evaluated the impact of the SkinVision mHealth app on dermatological healthcare consumption. The research focused on the frequency and type of dermatological claims between app users and a control group.
2023-08

Videos

Product demos, reviews, and walkthroughs for SkinVision.

View all on YouTube

Frequently Asked Questions

SkinVision is designed as a tool for individuals to self-check skin spots and receive an immediate risk indication (low or high) for common skin cancers. It aims to support early recognition and guide users on when to seek professional medical advice, rather than replacing a dermatologist's examination.
SkinVision is a CE-certified medical device app, having achieved the EU Medical Device Regulation (MDR) Class IIa certification. This signifies that it meets stringent European standards for safety, effectiveness, and reliability as a medical device for detecting skin cancer risk.
SkinVision has reported a sensitivity of 95.1% and specificity of 78.3% in detecting skin cancer in some studies. However, other studies suggest its performance can be inferior to dermatologists, with a tendency for over-detection of suspicious lesions, and it does not provide dermoscopic images for detailed analysis.
Yes, several other digital tools exist, including apps like Miiskin for mole tracking, MoleScope which uses an attachment for magnified images and sends them to a dermatologist, and First Derm for remote dermatologist consultations. ScanSkinAI and Aysa are also noted as AI-powered options with varying features and coverage for skin conditions.
SkinVision offers various pricing plans, including single checks, 3-month, or annual subscriptions, with costs varying by country. It is also accessible for free or at a discounted rate through partnerships with over 30 organizations worldwide, including health insurers and employers, making it reimbursed for over 20 million people.
SkinVision is designed to provide a risk indication (low or high) for skin spots and recommend whether a user should visit a healthcare professional for further review. It explicitly states that it does not provide a diagnosis and is not a substitute for a doctor or dermatologist.
SkinVision is ISO certified for information security (ISO 27001) and medical device management (ISO 13485), and declares explicit compliance with GDPR rules, storing data only in the EU. This ensures strong data protection and cybersecurity for user-submitted images and personal health information.

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Suggest an Edit → | Last Verified: 2026-05-12 | First Added: 2026-05-12
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