Fact checked by Nick Blackmer
The FDA has approved DermaSensor, the first medical device powered by artificial intelligence that’s designed to help healthcare providers detect the most common forms of skin cancer.
The device is not a general screening tool. Instead, it helps providers get a closer look at lesions that have already flagged as suspicious.
DermaSensor is only for prescription use by healthcare providers. It’s not intended for use by the general public or for home use.
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.
DermaSensor is 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 a news release.
Here’s how the DermaSensor device works and when your provider may use it, according to experts.
Related: What to Know About Skin Cancer
Like a Flashlight With AI
The DermaSensor device is meant to be used by healthcare providers who are not skin specialists, like a primary care provider. It will help them decide if the patient should be referred to a dermatologist to evaluate a suspicious skin lesion, Michele Green, MD, NYC cosmetic dermatologist at Northwell Lenox Hill Hospital, told Verywell.
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.
Here’s how DermaSensor works, step-by-step:
A primary care provider identifies a potentially cancerous skin lesion on a patient.
The physician positions the device against the lesion.
The device scans the lesion and takes several recordings.
DermaSensor’s AI algorithm analyzes the spectral data and gives the provider a result within a few seconds.
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?
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 like Merkel cell carcinoma, sebaceous carcinoma, and Kaposi’s sarcoma, Ariel Ostad, MD, a dermatologist and cosmetic surgeon in New York City, told Verywell.
Related: Who Is Most at Risk for Skin Cancer?
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.”
Related: What Does Skin Cancer Look Like?
How Can You Access the Device?
The DermaSensor device requires a prescription and is intended to be used by licensed health care practitioners, FDA communications officer Kristina Wieghmink, MEd, told Verywell. It is not intended for use by the general population or for home use.
Patients should ask their providers about DermaSensor, and providers who are looking to obtain the device should contact the company to 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 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.
Read the original article on Verywell Health.