DeepX receives FDA Clearance for digital dermatoscope DermoSight
DeepX Diagnostics, the skin cancer teledermatology and diagnostics company, has received clearance from the US Food and Drug Administration (FDA) for its digital dermatoscope DermoSight 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 180,000 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.
Christian Horn, the CEO at DeepX Diagnostics, 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.”
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.
Dr David Swanson, DeepX Diagnostics’ chief medical officer and professor of dermatology at Mayo Clinic, said: “Our technology has the potential to revolutionise 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.”
An initial study was conducted in cooperation with the Mayo Clinic using an AI integrated Dermosight prototype to analyse and diagnose skin cancer. The promising results from this study were published in the British Journal of Dermatology.
Hans Gangeskar, DeepX Diagnostics board member, and co-founder and former CEO of US telemedicine company Nurx added: “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. We are progressing well with our AI development and may be ready for further clinical trials of an integrated DermoSight version soon.”