FDA Greenlights DermaSensor: First AI Device for Detecting Skin Cancer

The Food and Drug Administration (FDA) has approved DermaSensor's groundbreaking AI-powered medical device, marking a pivotal moment as the first artificial intelligence-driven tool designed to assist doctors in identifying common forms of skin cancer.

CBS News reported that the AI medical device, developed by Miami-based firm DermaSensor, is engineered to evaluate lesions flagged as suspicious by doctors, emphasizing its role as a supplementary diagnostic tool rather than a screening device, according to the FDA.

The handheld, non-invasive DermaSensor uses AI-powered spectroscopy technology to look at the cellular and subcutaneous features of lesions. It gives real-time results by using an AI algorithm that has been trained on data from over 4,000 benign and malignant lesions. The device, targeted at primary care physicians, dermatologists, and other medical professionals, provides a "spectral similarity score" to known cases, enhancing a physician's assessment of moles or lesions.

Revolutionizing Skin Cancer Treatment

DermaSensor, positioned as a high-tech solution for skin cancer assessment, received approval for use in patients aged 40 and older. The FDA stresses the device's use in conjunction with clinically relevant information, including visual analysis, especially by non-dermatologist physicians.

The device operates through a straightforward process: a doctor identifies a potentially cancerous lesion, the wireless device records it, DermaSensor scans the lesion, and a proprietary algorithm analyzes spectral data, delivering a real-time assessment. Results may recommend further specialist investigation or monitoring without immediate further evaluation.

Cody Simmons, co-founder and CEO of DermaSensor, welcomed the FDA approval, highlighting how predictive and generative AI, spectroscopy, and genetic sequencing are improving disease detection and care.

DermaSensor screens moles for basal cell carcinoma and squamous cell carcinoma, in addition to melanoma, the most deadly skin disease With skin cancer affecting one in five Americans by age 70, DermaSensor offers a critical tool for early detection, potentially saving lives and reducing the substantial cost of skin cancer treatment in the U.S., estimated at over $8 billion.

According to the American Academy of Dermatology, skin cancer stands as the most widespread type of cancer in the United States, with an expected one in five Americans developing the condition in their lifetime. About 9,500 people in the United States receive skin cancer diagnoses every day, which adds up to an estimated annual number of over 3 million Americans who have nonmelanoma skin cancer. Increased exposure to UV radiation from sunlight or indoor tanning, along with a personal history of the disease, elevates the risk of all types of skin cancer.

The FDA approval comes with a stipulation for DermaSensor to conduct additional validation testing in patients from diverse demographic groups, including those at lower risk of skin cancer, ensuring the device's effectiveness across a broad population.

AI Now Being Used in Identifying Best Cancer Therapy

In another development, UC San Diego School of Medicine researchers are employing AI to improve cancer therapy. Cancer Discovery research uses AI to suggest the best cancer therapies based on tumor gene mutation complexity.

The AI, identifying 90 crucial genes for treatment decisions, aims to assist doctors in navigating the intricate landscape of cancer mutations and treatment options. Trey Ideker, Ph.D., emphasizes transparency and validation, ensuring the system explains its rationale and undergoes scrutiny by experts, potentially refining treatment decisions and extending life expectancy for cancer patients, as per a CBS 8 report.