DeepX Diagnostics Inc.'s DermoSight Receives FDA Clearance for Teledermatology Screening of Suspect Skin Cancer Lesions

DeepX Diagnostics Inc. to enter US market, having already performed over 180,000 skin lesions assessments in pharmacy and primary care to date in Europe.

WASHINGTON, June 6, 2023 /PRNewswire/ -- DeepX Diagnostics Inc., the skin cancer teledermatology and diagnostics company, announced today that its digital dermatoscope DermoSight^TM received clearance from the US Food and Drug Administration (FDA) for teledermatology screening of suspect skin cancer lesions in the United States. The company is now ready to enter the US market on the back of over 180 thousand assessments in pharmacies and primary care clinics in Europe.

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. The technology is designed to turn dermatoscopic assessment into a robust, non-invasive and accessible AI driven tool, and to streamline and fast-track skin cancer diagnosis.

"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," said Christian Horn, the CEO at DeepX Diagnostics.

Teledermatology assessments in primary care clinics and pharmacies can help streamline the detection of cancerous lesions and fast-track their diagnosis, while reducing unneeded referrals and procedures for non-cancerous lesions. Today, skin cancer is mainly diagnosed by a dermatologist through a biopsy, which means long wait times and costly and invasive procedures.

"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," said dermatologist Dr David Swanson, DeepX Diagnostics' Chief Medical Officer and Professor of Dermatology at Mayo Clinic.