This IRB approval marks the next step in the Sklip’s progression towards FDA Clearance review of Sklip System AI for consumer use.

Sklip System AI for safe, effective and regulated consumer use

Sklip Inc  has received academic hospital based institutional review board (IRB) approval to clinically test Sklip artificial intelligence (AI) skin cancer triage with patients in home settings. 

Sklip System AI, which previously received US Food and Drug Administration (FDA) Breakthrough Designation status, is a software as a medical device tool that uses proprietary artificial intelligence technology to triage skin cancers using digital dermoscopy images.

Sklip makes it easy for users to acquire these images on their own smartphones when using a patent pending Sklip dermatoscope attachment. The Sklip attachment does not require an adapter and when aligned with a smartphone rear facing camera, allows the user to take high-definition medical grade images of self-selected moles of concern. The use of Sklip System AI can identify early signs of skin cancer with an accuracy above 95%.

This IRB approval marks the next step in the Sklip’s progression towards FDA Clearance review of Sklip System AI for safe, effective, and regulated consumer use. Used as a home-based digital health tool, Sklip artificial intelligence triage has the potential to reduce wait times to see a dermatologist from an average of 6 months to 10 days.

The company was founded by husband and wife, European trained dermatologists, Alexander Witkowski MD, PhD and Joanna Ludzik MD, PhD, who currently practice dermatology in the United States.