FDA Approves New AI Device to Detect Skin Cancer

The new handheld medical device uses AI-powered spectroscopy technology to help healthcare providers detect three common types of skin cancer.

On Friday, January 12, the U.S. Food and Drug Administration (FDA) approved DermaSensor — an AI-powered prescription device — to help primary care providers (PCPs) determine whether suspicious skin lesions could be melanoma, basal cell, or squamous cell carcinoma.

The FDA says that doctors should not use the device to confirm a skin cancer diagnosis. Instead, if DermaSensor indicates that a lesion may be cancerous, the healthcare provider should refer the person to a dermatologist.

As a condition of marketing approval, the FDA requires that DermoSensor makers conduct further post-market performance testing of the device to ensure it works in people who are less likely to develop skin cancer but more likely to experience poorer outcomes, such as Black individuals.

How does DermaSensor work?

According to the company's website, a healthcare provider simply positions the device on a suspicious skin lesion, and it will take five spectral recordings. An algorithm analyzes the data and delivers one of two results.

An "Investigate Further" result means the patient should have the lesion evaluated by a dermatologist, and a "Monitor" result suggests there's no need for further evaluation at that time.

The company says the FDA's approval is based on a Mayo Clinic study involving over 1,000 participants. The findings showed the device had a sensitivity of 96% across all 224 skin cancers, and a negative result had a 97% chance of being benign. A companion study revealed that the DermaSensor system reduced the number of missed skin cancer diagnoses by 50%.

According to a Reuters report, the device will be priced as a subscription. Healthcare providers can pay $199 per month for five patients or $399 a month for unlimited use.

In a press release, Cody Simmons, co-founder and Chief Executive Officer of DermaSensor, said, "Equipping PCPs, the most abundant clinicians in the country, to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine. While dozens of companies have attempted to address this problem in recent decades, we are honored to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions."


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