The first FDA-cleared, AI-powered handheld device that checks a suspicious mole for skin cancer - in the exam room, in seconds, without a single cut.
A primary care doctor in 2026 has roughly fifteen minutes, a worried patient, and a spot on a shoulder that may be nothing. The old options were two: refer to a dermatologist and hope the patient actually goes, or eyeball it and move on. DermaSensor added a third. The doctor presses a small white wand to the lesion, the device fires hundreds of wavelengths of light into the skin, and a few seconds later the screen says either "monitor" or "investigate further." No scalpel. No three-week wait. No coin flip.
That wand is the entire company. DermaSensor, headquartered on Brickell Avenue in Miami, builds exactly one thing - a handheld, AI-powered skin cancer detection device - and it has spent the better part of two decades making it small enough to matter.
Skin cancer is the most common cancer in the world, and the people most likely to spot it first are not dermatologists. They are family doctors, internists, the clinician you already see. The trouble is that telling a harmless mole from an early melanoma by eye is genuinely hard, and there are nowhere near enough dermatologists to look at every patient who has a suspicious spot. Patients fall into the gap. Some get referred and never follow through. Some get reassured and shouldn't be.
The conventional fix - train more dermatologists, build more clinics - is slow and expensive, which is to say it is the kind of fix that sounds responsible and never quite arrives. DermaSensor's bet was that the better lever was the doctor the patient was already standing in front of.
DermaSensor was founded in 2009 by Maurice Ferre, a medical device veteran who became chairman, and Christopher Dewey. The spark came from conversations with Dr. Irving Bigio, a Boston University biomedical engineering professor who had invented elastic scattering spectroscopy - ESS - back in 1994. ESS reads how light bounces off the cellular and subcellular structure of tissue. Cancerous cells scatter light differently than healthy ones. The physics was sound. The packaging was not.
Cody Simmons joined in 2014 and is now co-founder and CEO. When he arrived, the technology existed as roughly 30-pound machines built in a university lab - impressive, and completely unusable in a clinic. The company's real work was less about inventing the science and more about the unglamorous engineering of shrinking it: from microwave-sized hardware to a device a doctor holds in one hand, and from spectral data that took days to interpret to a machine learning algorithm that answers in seconds.
The device is non-invasive by design. It does not biopsy, cut, or break the skin. It shines hundreds of light wavelengths into a lesion, captures how that light scatters, and feeds the spectral signature into an algorithm trained on thousands of dermatopathology-confirmed tissue samples. The output is deliberately simple - a binary nudge to either keep an eye on the spot or send it onward. It is built to support a physician's judgment, not replace it.
The single most useful thing about it is also the least dramatic: it gives a non-specialist a defensible second opinion at the exact moment of the visit. The patient never leaves the room without an answer about whether they need to worry.
Dr. Irving Bigio invents elastic scattering spectroscopy at Boston University - the physics DermaSensor would later license and build on.
Maurice Ferre and Christopher Dewey found DermaSensor in Miami to bring ESS to skin cancer detection.
Skin-specific ESS studies begin in earnest.
Cody Simmons joins; the technology is still a 30-pound lab machine awaiting miniaturization.
Studies begin on the current commercial-form device.
DERM-SUCCESS pivotal study results unveiled, including performance data across skin tones in over 1,000 patients.
FDA clearance granted - the first AI-powered device to detect all three common skin cancers.
$16M Series B raised to scale into more primary care practices; CE mark secured for Europe.
The pivotal DERM-SUCCESS study was led by the Mayo Clinic across 22 primary care study centers and enrolled more than 1,000 patients. The headline result: the device flagged skin cancers with roughly 96% sensitivity, compared with about 83% for the primary care physicians on their own. In other words, putting the device in a generalist's hand closed most of the gap between a family doctor and a specialist.
Bars are approximate study figures. The device's negative predictive value landed near 97%, and reported sensitivity was highest for basal and squamous cell carcinoma and lower for melanoma. Roughly one in six lesions it flags turns out to be cancer.
Adoption followed the evidence rather than the hype. By 2025 the device was deployed across seven health systems and more than 200 doctor locations, with over 20,000 lesions scanned and an average quarterly growth rate reported around 117% since the U.S. commercial launch. The October 2025 Series B - $16M, with Pier 70 Ventures, Kern Venture Group, GenHenn Capital and an undisclosed strategic investor - is aimed squarely at putting more wands in more exam rooms.
The peopleJoined in 2014; leads the company's push into primary care.
Medical device veteran; co-founded the company in 2009.
Co-founded DermaSensor alongside Ferre.
The stated goal is plain: improve patient access to effective, early skin cancer assessment by equipping frontline providers - not just specialists - with serious diagnostic tools. The ambition behind it is bigger. If catching skin cancer early stops being a specialty event and becomes a routine part of a regular checkup, the math of the disease changes. Early detection is the whole game, and the cheapest place to play it is the visit you were already going to have.
Go back to that exam room. Fifteen minutes, a worried patient, a spot on a shoulder. The difference DermaSensor is selling is not a miracle and it does not pretend to be one - it is the removal of the coin flip. The doctor presses a wand to the skin, the light does its reading, and the patient gets an answer before they put their jacket back on. The dermatologist shortage is still real. The waitlists are still long. But the first, most important look no longer has to wait for any of that. That is the quiet revolution: not a smarter specialist, but a more capable generalist, holding a device that turns a guess into a measurement.