SkinVision, a global leader in AI-powered skin health services, today 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.
The collaboration is conducted under a research collaboration agreement with Mayo Clinic, which governs the exchange of scientific expertise and supports the execution of an innovative study.
The incidence of melanoma and non-melanoma skin cancer continues to rise, while timely access to dermatologic care remains limited for many patients across the United States. National workforce shortages, insurance-related barriers, and the uneven geographic distribution of dermatologists contribute to long waiting times and delayed evaluations. These system-level challenges are compounded by socioeconomic factors – income, education level, and transportation access – that disproportionately affect vulnerable populations and increase the risk of later-stage diagnosis and poorer outcomes.
The pivotal study will evaluate the performance and intended use of the SkinVision app’s AI-based assessment for skin spots, while exploring how digital tools may help improve access to dermatology guidance across the United States.
Advancing Clinical Evidence and Regulatory Readiness
This research collaboration represents an important step in SkinVision’s regulatory and scientific development, with the goal of generating robust clinical evidence to support FDA clearance and to validate the technology app within the U.S. population.
Improving Access to Dermatology Care
SkinVision is designed to help people document and monitor skin spots of concern by guiding them in capturing high-quality photos and relevant information during a skin self-examination. The app provides an informational indication when a spot may benefit from evaluation by a qualified healthcare professional. SkinVision is committed to delivering accessible, research-backed, and affordable digital skin health solutions to individuals and communities across the United States.
A Major Milestone for SkinVision
Erik de Heus, CEO of SkinVision, said: “This pivotal trial marks a significant scientific and regulatory milestone for SkinVision. We are excited to collaborate with Mayo Clinic on this research as we continue to build clinical evidence to support our technology. This study represents an important step toward making trusted, AI-powered skin health guidance available to users across the United States.”
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
