DermaSensor announced the U.S. Food and Drug Administration cleared its non-invasive skin cancer detection device.
The Miami company is the maker of a handheld tool that can examine tissue samples and capture critical information using wavelengths of light. The technology makes it possible for primary care doctors to identify skin cancer on patients without having to wait for lab results or a diagnosis from a specialist.
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“Equipping [physicians] to better evaluate the most common cancer in the country has been a major, long-standing unmet need in medicine," said CEO Cody Simmons.
A medical device can receive clearance, a step below FDA approval, if a manufacturer demonstrates the product is substantially equivalent to a similar device on the market that has already been cleared or approved. FDA clearance means the DermaSensor device can now be sold in the U.S.
DermaSensor was founded in 2009 by medical technology investors Christopher Dewey and Dr. Maurice Ferré. They launched the business in collaboration with Dr. Irving Bigio, a spectroscopy research and professor of biomedical engineering at Boston University.
About one in five Americans will develop skin cancer – the most common of all cancers – in their lifetime, according to the American Cancer Society.
Melanoma accounts for 1% of all diagnoses. If treated early, it has a 99% five-year survival rate. If not, it can spread to other parts of the body and may not be curable.
According to a study published in the Journal of the American Academy of Dermatology, DermaSensor's medical device is able to detect lesions suggestive of melanoma, basal cell carcinoma and squamous cell carcinoma with 97% accuracy. That's comparable to an in-person assessment with a dermatologist, the study said.
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DermaSensor co-founder and chairman Ferré described the FDA clearance as a "medical milestone."
"It 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,” he said.
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