DeepX Diagnostics has received clearance from the US Food and Drug Administration (FDA) for its digital dermatoscope DermoSight for teledermatology screening of suspect skin cancer lesions.

DermoSight is intended for skin cancer screening. Currently, the device is approved to acquire skin lesion images for teledermatology evaluation, like prevailing digital dermatoscopes.

It was first approved for commercial use in Europe for teledermatological skin cancer screening. At present, it is used in primary care settings as part of the UK National Health Service (NHS) services and in community pharmacies in Europe, including the Walgreens Boots Alliance pharmacy chain Boots, in the UK as well as Ireland.

DeepX Diagnostics now plans to enter the US market with experience of over 180,000 skin lesions assessments across pharmacies and primary care clinics in Europe.

DeepX Diagnostics CEO Christian Horn said: “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.”

DermoSight has been designed by the skin cancer teledermatology and diagnostics company for integration with an artificial intelligence (AI) algorithm powered by proprietary optical transfer diagnosis (OTD) technology.

OTD technology is designed to analyse deep layers of suspicious skin lesions below the surface of the skin based on their light-transferring properties via optical analysis.

It intends to transform dermatoscopic assessment into a non-invasive and accessible AI-driven tool and to streamline and expedite skin cancer diagnosis, according to the teledermatology company. However, the use of OTD technology with DermoSight remains subject to FDA approval.

The teledermatology firm conducted an initial study in partnership with the US-based Mayo Clinic using an AI-integrated Dermosight prototype to assess and diagnose skin cancer. The results from the study were published in the British Journal of Dermatology.