Key Takeaways

The Food and Drug Administration (FDA) has approved the first artificial intelligence (AI) powered medical device that can help providers detect the most common forms of skin cancer.

DermaSensoris an AI-powered wireless, handheld device equipped with a software algorithm that can analyze the appearance of a patient’s suspicious skin lesion and give providers insight into what steps to take next.

According to the manufacturer, the device will allow 300,000 primary care providers (PCPs) in the U.S. to offer point-of-care medical diagnostic testing for common types of skin cancer. Early detection can help make sure that patients who need more care, whether it’s a referral to a specialist or follow-up for treatment, get access to it sooner rather than later.

“To date, PCP’s limited options for evaluating suspicious moles have been the naked eye or magnified visual examination of lesions, both of which are dependent on clinical training and subjective judgment,” the company stated in anews release.

Here’s how the DermaSensor device works and when your provider may use it, according to experts.

What to Know About Skin Cancer

Like a Flashlight With AI

The device allows providers to shine light on a patient’s skin lesion. The light then reflects off the cellular structures beneath it. This technique, called elastic scattering spectroscopy, allows for a much closer look than what a provider can see with the naked eye.

If DermaSensor gives a result of “Investigate Further,” the provider should refer the patient to a specialist or dermatologist for further evaluation of the lesion.

A result of “Monitor” suggests the skin lesion does not warrant an immediate need for a specialist referral.

DermaSensor is not a general skin cancer screening tool, and it can’t confirm a skin cancer diagnosis.

“This device should only be used after a healthcare provider has performed a full clinical assessment of the skin lesion,” Green said.

In an FDA study of over 1,000 patients, the DermaSensor had a sensitivity of 96% across all 224 skin cancers.

What Types of Skin Cancer Can It Detect?

The DermaSensor can help providers detect three common skin cancers, includingmelanoma,basal cell carcinoma, orsquamous cell carcinomain people aged 40 and older.

However, these are not the only types of skin cancer that a suspicious lesion could be. The device is not intended to help detect rare types of skin cancer likeMerkel cell carcinoma, sebaceous carcinoma, andKaposi’s sarcoma,Ariel Ostad, MD, a dermatologist and cosmetic surgeon in New York City, told Verywell.

Avoiding Unnecessary Care

The main benefit of using the DermaSensor device is that it can give healthcare providers more information to help them decide whether a patient needs to be referred to a dermatologist, according to Green.

Since skin lesions come in all different shapes, sizes, and colors, it can be hard for providers who are not specialists to determine if a skin lesion needs further evaluation, added Green. The device can help providers make more informed decisions about referring patients to a skin specialist, ultimately saving patients from unnecessary visits and avoiding extra medical costs.

“This device will allow providers to have more accuracy in their dermatology referrals and save patients an unnecessary trip and expense to a specialist,” said Green. “However, this tool should not be a substitute for an annual skin check with a dermatologist and should be used for discrete skin lesions that are already suspicious of skin cancer.”

On the flip side, the fact that DermaSensor is only meant to be used when a provider already thinks that a skin lesion could be a limitation. That’s because many primary care providers aren’t well-versed in skin cancers, according to Ostad.

“PCPs are not experts in skin cancers. My concern is that this will replace a dermatologist seeing a patient properly,” said Ostad. “This device may end up missing skin cancer if the PCP doesn’t fully examine the skin like a dermatologist would.”

What Does Skin Cancer Look Like?

How Can You Access the Device?

Patients should ask their providers about DermaSensor, and providers who are looking to obtain the device shouldcontact the companyto learn more, according to Green.

If your provider does not have access to the device, Green said the number one way to get screened for skin cancer is to visit a dermatologist for a yearly check-up. A dermatologist will closely examine all areas of your body, looking for new growths and irregularities in color, shape, size, and texture.

“Any skin lesions suspicious of skin cancer will be biopsied and sent to a laboratory for further testing to confirm a diagnosis,” said Green. “Patients should check their skin regularly for new growth and visit a dermatologist if a mole seems unusual or a growth has changed in appearance.”

What This Means For YouThe newly FDA-approved DermaSensor is not a general skin cancer screening tool, and patients can’t access it themselves or use it at home. Instead, it’s meant to be a tool to help providers make informed decisions about referring patients who may have suspicious skin lesions to dermatologists.

What This Means For You

The newly FDA-approved DermaSensor is not a general skin cancer screening tool, and patients can’t access it themselves or use it at home. Instead, it’s meant to be a tool to help providers make informed decisions about referring patients who may have suspicious skin lesions to dermatologists.

3 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.FDA Roundup: January 16, 2024.Food and Drug Administration.Product classification.DermaSensor.FDA clearance granted for first AI-powered medical device to detect all three common skin cancers (melanoma, basal cell carcinoma and squamous cell carcinoma).

3 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.FDA Roundup: January 16, 2024.Food and Drug Administration.Product classification.DermaSensor.FDA clearance granted for first AI-powered medical device to detect all three common skin cancers (melanoma, basal cell carcinoma and squamous cell carcinoma).

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food and Drug Administration.FDA Roundup: January 16, 2024.Food and Drug Administration.Product classification.DermaSensor.FDA clearance granted for first AI-powered medical device to detect all three common skin cancers (melanoma, basal cell carcinoma and squamous cell carcinoma).

Food and Drug Administration.FDA Roundup: January 16, 2024.

Food and Drug Administration.Product classification.

DermaSensor.FDA clearance granted for first AI-powered medical device to detect all three common skin cancers (melanoma, basal cell carcinoma and squamous cell carcinoma).

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