FDA clears digital dermatoscope from DeepX Diagnostics

Jan 04, 2024

June 6, 2023 By Sean Whooley

The DermoSight scope is used for teledermatology screening of suspect skin cancer lesions. Washington-based DeepX Diagnostics plans to enter the U.S. market having already completed more than 180,000 assessments in Europe.

FDA clearance for DermoSight covers the acquisition of skin lesions for teledermatology assessment, similar to existing digital dermatoscopes. DeepX Diagnostics designed it for integration with an AI algorithm powered by proprietary optical transfer diagnosis (OTD) technology.

OTD technology enables the analysis of lesions on the sub-skin level based on light-transferring properties. DeepX Diagnostics aims for this technology to turn dermatoscopic assessment into a robust, non-invasive and accessible AI-driven tool. However, use of OTD technology with DermoSight remains subject to further FDA approval. If approved, it could streamline and fast-track skin cancer diagnosis, according to a news release.

Hans Gangeskar, a DeepX Diagnostics board member, said the company is progressing well with its AI development. Gangeskar teased further clinical trials of the integrated DermoSight version "soon."

"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 Dr. David Swanson, DeepX Diagnostics chief medical officer. A dermatologist, Swanson also serves as a professor of dermatology at Mayo Clinic.

Filed Under: Business/Financial News, Diagnostics, Digital Health, Food & Drug Administration (FDA), Health Technology, Imaging, Oncology, Regulatory/Compliance, Software / IT Tagged With: DeepX Diagnostics