One in five Americans will develop skin cancer by age 70. Skin cancer remains the most common cancer globally, and while many skin cancer cases are preventable through sun protection and early detection, delayed diagnoses drive up healthcare costs – and morbidity.
Fortunately, commercialization is underway for DermaSensor, the Miami-based startup that has recently gone to market with the first FDA-authorized tool in the US that provides an objective risk assessment for deadly melanoma and other forms of skin cancer. Now, the publication of two pivotal FDA studies sheds light on the company’s potential impact. Together they showed that DermaSensor’s hand-held AI-powered device detected skin cancer with 96% sensitivity and also helped primary care physicians cut missed skin cancer referrals in half.
In collaboration with faculty from Mayo Clinic, Yale University, the University of North Carolina School of Medicine, and SUNY Downstate Health Sciences University, one study assessed the performance of DermaSensor’s device, while the second evaluated how primary care physicians’ use of the device impacted skin cancer detection and management.
In the multicenter validation study led by Mayo Clinic, 1,005 patients and 1,579 lesions were evaluated across 22 primary care sites. Dermatopathologic analysis confirmed 224 skin cancers, including melanomas, basal cell carcinomas, and squamous cell carcinomas. DermaSensor’s device was found to have a skin cancer detection rate, or sensitivity, of 96%, the company said. For negative device results, the likelihood that a lesion was benign was 97%, the study found.
The companion clinical utility study, with 108 physicians, found that device use significantly enhanced physicians’ ability to identify and correctly refer skin cancers and improved their overall skin lesion management accuracy. Primary care physicians correctly referred 91.4% of malignant lesions when aided by the device, compared to just 82.0% without it; that amounted to a 50% reduction in missed cancer referrals.
“Since receiving FDA De Novo clearance of this FDA Breakthrough Device last year, there are already hundreds of diverse doctors using our devices, and we are working to quickly scale device adoption so that our device can benefit many of the millions of patients that are diagnosed with skin cancer each year,” said DermaSensor co-founder and CEO Cody Simmons.
The road to FDA clearance, obtained a year ago, was an eight-year endeavor for Simmons, who came aboard as CEO in January of 2016 after leading business development for a Silicon Valley medical device startup and before that worked at Genentech. It was an even longer journey for Miami medtech serial entrepreneur Maurice Ferre, who started it all, believing that early detection of skin cancer is a public health issue because not enough people have access to dermatologists.
DermaSensor’s device, which combines the power of artificial intelligence with patented spectroscopy technology, is the first real-time skin cancer device designed for primary care physicians and the only one that can detect melanoma, basal cell carcinoma and squamous cell carcinoma, the three most common forms of the cancer.
Now six health systems and hundreds of physicians at private practices are using the device, Simmons told Refresh Miami. In the first quarter of this year, usage had risen to over 4,600 customer scans per quarter. A leading Miami health system is among the first health systems to use the device, he said.
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