The US Food and Drug Administration (FDA) has granted clearance to DermaSensor for its AI-powered skin cancer detection device.
The technology is designed to offer primary care physicians a real-time, non-invasive tool to detect all common skin cancers, melanoma, basal cell carcinoma and squamous cell carcinoma.
DermaSensor co-founder and chairman Dr Maurice Ferre said: “Achieving this medical milestone is a testament to the 12 years and tens of millions of dollars our company has invested in research and development to bring this powerful technology to market.
“Having begun patient enrolment in our FDA pivotal study in mid-2020, we are now ecstatic to have clearance of our FDA-breakthrough designated De Novo submission.”
DermaSensor’s AI-powered spectroscopy technology allows physicians to non-invasively assess cellular and subcellular characteristics of a lesion for skin cancer.
Subsequently, the wireless handheld device provides an immediate, objective result using an algorithm cleared by the FDA.
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The FDA pivotal study, which included more than 1,000 patients and was led by the Mayo Clinic across 22 study centres, demonstrated a 96% sensitivity rate for the device across all 224 skin cancers identified.
Furthermore, a negative result from the device indicated a 97% probability of the lesion being benign.
In a related clinical utility study involving 108 physicians, the use of the DermaSensor device halved the number of missed skin cancers, reducing the rate from 18% to 9%.
This not only increased the accuracy of cancer assessments but also boosted physician confidence, the company noted.
DermaSensor co-founder and CEO Cody Simmons said: “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 optimise disease detection and care.
“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.
“While dozens of companies have attempted to address this problem in recent decades, we are honoured to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions.”
In November 2023, DermaSensor announced that a newly published study of its AI-powered elastic scattering spectroscopy device demonstrated its potential for detecting skin cancer.
