MedikalDevice

SkinVision Skin Cancer Risk App

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SkinVision Skin Cancer Risk App

A smartphone app (software, not a hardware scanner) that analyzes a photo of a skin spot and gives a low- or high-risk indication for skin cancer, advising whether to see a doctor. Consumer use.

Key facts

ProductSkinVision
ManufacturerSkinVision B.V. (Amsterdam, Netherlands)
Intended usersHome / personal use
US FDA statusNot FDA-cleared (wellness/consumer)
Market statusAvailable

Main features

  • Uses the smartphone camera; no separate hardware
  • Algorithm gives a low/high risk indication per skin spot
  • CE-marked medical device app, EU MDR Class IIa (Aug 2025)

Connectivity

Smartphone app (iOS/Android) with cloud-based analysis.

AI and analysis software

AI image-analysis algorithm for skin lesion risk assessment.

Software outputs are an aid to the clinician, not a diagnosis, and are limited to the indications cleared for each feature.

Regulatory status in the United States

We found no FDA clearance or approval for this product. It should not be relied on for diagnosis in the United States. Not FDA-authorized; US pivotal trial with Mayo Clinic announced March 2026; app not available in the US.

Related guide: Dermatoscopes With Built-In AI.

Sources

Profile verified against public sources in October 2026. Trademarks belong to their owners.