FDA Approves AI Device That Helps Spot Skin Cancer
By Robin Foster HealthDay Reporter
THURSDAY, Jan. 18, 2024 (HealthDay news) -- The first medical device powered by artificial intelligence and designed to help doctors catch skin cancer has been approved by the U.S. Food and Drug Administration.
Although not meant to be used as a primary screening tool, the technology further evaluates skin lesions that doctors have already flagged as suspicious, the FDA noted in an agency news release.
The handheld device uses AI-powered spectroscopy to assess the characteristics of lesions at both the cellular level and beneath the skin's surface.
“We are entering the golden age of predictive and generative artificial intelligence in healthcare, and these capabilities are being paired with novel types of technology, like spectroscopy and genetic sequencing, to optimize disease detection and care,” DermaSensor Inc. co-founder and CEO Cody Simmons said in a company news release. “Equipping PCPs [primary care physicians], 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.”
The device, also called DermaSensor, provides real-time results using an algorithm based on data culled from more than 4,000 malignant and benign lesions, according to the company.
"The device should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists," the FDA said, adding that DermaSensor is for use in patients ages 40 and up.
Along with helping to spot melanoma, the most deadly form of skin cancer, the device can also assess moles for basal cell carcinoma and squamous cell carcinoma.
One in five Americans will have developed a form of skin cancer by the age of 70, according to the American Academy of Dermatology, which puts the cost of treatment in the United States at more than $8 billion. Most skin cancers are curable if detected early.
The FDA added that it is requiring additional validation testing in patients from representative demographic groups, including those who are at lower risk of skin cancer.
Sources
- U.S. Food and Drug Administration, news release, Jan. 16, 2024
- DermaSensor Inc., news release, Jan. 17, 2024
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted January 2024
Read this next
Texas Rancher Developed Anthrax From Butchered Lamb Meat
FRIDAY, June 7, 2024 -- Anthrax disease in humans is rare and when it does occur, it's usually during hot, dry summers. That's why the case of a Texas rancher who developed...
Could Brain 'Overgrowth' Contribute to Autism?
FRIDAY, June 7, 2024 -- Severe forms of autism could be linked to overgrowth of the brain’s outer layer that starts while a baby is in the womb, a new study finds. Toddlers...
Patient in Mexico Dies From First Known Human Infection of H5N2 Strain of Bird Flu
THURSDAY, June 6, 2024 -- A 59-year-old person in Mexico is the first human in the world known to be infected with the H5N2 strain of avian flu, and the patient died of...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.