DermoSight is also designed for integration with an AI algorithm.

The US Food and Drug Administration (FDA) has cleared DeepX Diagnostics Inc.’s  digital dermatoscope DermoSight for teledermatology screening of suspected skin cancer lesions.

DermoSight is currently cleared to acquire skin lesion images for teledermatology assessment, like existing digital dermatoscopes. It is also designed for integration with an AI algorithm, empowered by proprietary optical transfer diagnosis (OTD) technology, although the FDA has yet to approve the commercial use of the OTD technology with DermoSight.  OTD enables the analysis of lesions on the sub-skin level based on their light transferring properties. 

"We are delighted to announce that the FDA has cleared DermoSight for use in the United States. It will help people with skin lesions of concern receive early diagnosis and effective treatment of skin cancer," says Christian Horn, the CEO at DeepX Diagnostics, in a news release.

"Our technology has the potential to revolutionize the way skin cancer is diagnosed, by turning the dermatoscope from a sophisticated tool for the dermatologist's eye into a precise diagnostic instrument, comparable to biopsy in accuracy, through its future integration with an AI augmented OTD algorithm," adds dermatologist Dr. David Swanson, DeepX Diagnostics' Chief Medical Officer and Professor of Dermatology at Mayo Clinic in Rochester, Minn.

"DermoSight is only the first step in our vision to make skin cancer diagnosis directly accessible in primary care and beyond, and to reduce referrals and waiting times, which we know increase cost and make early detection less likely," says Hans Gangeskar, DeepX Diagnostics board member, and co-founder and former CEO of US telemedicine company Nurx. "We are progressing well with our AI development and may be ready for further clinical trials of an integrated DermoSight version soon."

DermoSight is currently being used in primary care settings as part of NHS services and in community pharmacies in Europe, including the Walgreens Boots Alliance pharmacy chain Boots, in the UK and Ireland.