DermaSensor received FDA clearance for its real-time, non-invasive skin cancer evaluation system.
One out of five Americans will have had some type of skin cancer by the age of 70, and the annual cost of treating skin cancers in the U.S. is estimated at $8.1 billion. A majority of skin cancers, including the most deadly form, melanoma, are curable if detected early. Access to dermatology is challenging, especially in rural areas, which makes empowering primary care to identify those cases warranting a referral even more vital, according to DermaSensor.
DermaSensor’s AI-powered spectroscopy technology can non-invasively evaluate cellular and subcellular characteristics of a lesion for skin cancer. The wireless, handheld device then provides an immediate, objective result using an FDA-cleared algorithm.
An FDA study of over 1,000 patients, led by the Mayo Clinic showed that the device had a sensitivity of 96% across all 224 skin cancers. A negative result had a 97% chance of being benign for all skin cancers. In a companion clinical utility study with 108 physicians, the DermaSensor device was found to decrease the number of missed skin cancers by half (from 18% to only 9%), increasing the physicians’ accuracy and confidence in assessing cancerous lesions.
“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,” said Cody Simmons, co-founder and chief executive officer of DermaSensor. “Equipping PCPs, 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 honored to be the first device cleared by the FDA that provides PCPs with an automated tool for evaluation of suspicious lesions.”
DermaSensor is expected to improve primary care and dermatology collaboration, enabling better-prioritized referrals in addition to the referral of more patients with skin cancer. The company has conducted 13 clinical studies in the last decade, six of which provided the principal support for FDA clearance.
“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,” said Dr Maurice Ferre, co-founder and chairman of DermaSensor. “We are incredibly grateful to the FDA for their collaboration and dedication to this area starting with our first FDA pre-submission meeting in 2016.”