Emerging according to researchers and dermatologists investigating AI.
While some AI-integrated devices designed to triage skin lesions have emerged, including one that received Food and Drug Administration (FDA) clearance earlier in 2024, it may be some time before AI has a meaningful clinical impact in dermatology and, more specifically, the diagnosis of skin cancer, Ivy Lee, MD, a dermatologist in Pasadena, California, and chair of the American Academy of Dermatology’s augmented intelligence committee, told this news organization.
courtesy Dr. Ivy Lee
Dr. Ivy Lee
“It hasn’t really translated into clinical practice yet,” Dr. Lee said of AI in dermatology. “There have been significant advances in terms of the technical possibility and feasibility of these tools, but the translation and integration of AI into actual clinical work flows to benefit patients beyond academic research studies has been limited.” More studies and more “easily accessible and digestible information” are needed to evaluate AI tools in dermatologic practice.
“In dermatology, we’re on a cusp with AI,” said Rebecca Hartman, MD, MPH, chief of dermatology at the VA Boston Healthcare System and director of melanoma epidemiology at Brigham and Women’s Hospital, Boston, Massachusetts. “I think it’s going to come and change what we do,” which is especially true for any image-based specialty,” including radiology and pathology, in addition to dermatology.
Dr. Rebecca Hartman
Dr. Hartman led a study of one of these emerging technologies, the handheld elastic scattering spectroscopy device DermaSensor, which was cleared by the FDA in January for evaluating skin lesions suggestive of skin cancer.
Early AI Devices for Skin Cancer Detection
At the American Society for Laser Medicine and Surgery (ASLMS) meeting in April, a panel explored a number of algorithms with dermatologic applications that use AI to triage skin lesions, including DermaSensor.
Raman spectroscopy, which contains a handheld Raman probe, a diode laser, and a detecting spectrograph. A laser beam — which at 1.56 W/cm2 is below the maximum permissible exposure — focuses on the skin target with a 3.5-mm spot, gathers data on the target, and feeds it back into the unit that houses the algorithm that evaluates the spot analysis. It’s still in the investigative phase. A clinical trial, published almost 5 years ago, demonstrated a sensitivity of 90%-99% and a specificity of 24%-66% for skin cancer.
A dermatoscope called Sklip clips onto a smartphone and performs what company cofounder Alexander Witkowski, MD, PhD, described as an “optical painless virtual biopsy” for at-home use. The device uploads the captured image to an AI platform for analysis. It received FDA breakthrough device designation in 2022. At the ASLMS meeting, Dr. Witkowski said that clinical performance showed the device had a 97% sensitivity and 30% specificity for skin cancer.
courtesy DermaSensor
DermaSensor, an AI-powered device cleared by FDA to help primary care physicians evalaute skin lesions and determine which should be referred to a dermatologist.
DermaSensor, described in the study conducted by Dr. Hartman and others as a noninvasive, point-and-click spectrometer, is a wireless handheld piece that weighs about 10 ounces. The unit captures five recordings to generate a spectral reading, which an algorithm in the software unit analyzes. The study found a sensitivity of 95.5% and specificity of 32.5% for melanoma detection with the device.
The target market for DermaSensor is primary care physicians, and, according to the FDA announcement in January, it is indicated for evaluating skin lesions “suggestive” of melanoma, basal cell carcinoma (BCC), and/or squamous cell carcinoma (SCC) in patients aged 40 and older to “assist healthcare providers in determining whether to refer a patient to a dermatologist.”