DermaSensor

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DermaSensor Inc. is a medical device company based in Miami, Florida. The company developed DermaSensor, an AI-powered handheld device that uses elastic scattering spectroscopy to assess skin lesions for the risk of skin cancer. DermaSensor was founded in 2009 by Dr. Maurice Ferré and Chris Dewey. Cody Simmons joined them as co-founder and Chief Executive Officer in 2016. On January 12, 2024, the U.S. Food and Drug Administration (FDA) granted marketing authorization for the device through the De Novo pathway as a Class II device, as the first AI-enabled medical device intended for skin cancer assessment in primary care. DermaSensor assesses lesions suggestive of melanoma, basal cell carcinoma and squamous cell carcinoma. The device indicates whether a lesion should be investigated further or monitored.

History

DermaSensor was founded in 2009 by Maurice Ferré and Chris Dewey. Cody Simmons joined the company as chief executive officer in 2016 and has also been identified as a co-founder.

The device was developed using elastic scattering spectroscopy (ESS), an optical technique developed and refined by Boston University biomedical engineer Dr. Irving Bigio. DermaSensor licensed related patents from Dr. Bigio and Boston University. Development of the device began around 2011–2012. An early version was a roughly 30-pound system that was subsequently miniaturized into a handheld device. In 2016, the company held its first pre-submission meeting with the FDA based on data from an earlier version of the device.

Enrollment in the DERM-SUCCESS pivotal study began in 2020. In 2021, the device received FDA Breakthrough Device designation. In 2020, DermaSensor raised $11.5 million in Series A financing, followed by a $10 million financing round in 2022.

In 2023, the DermaSensor device received recognition from the Edison Awards and the MedTech Breakthrough Awards.

On January 12, 2024, the FDA granted marketing authorization for DermaSensor through the De Novo pathway. The authorization covers use by physicians who are not dermatologists to evaluate lesions suggestive of melanoma, basal cell carcinoma or squamous cell carcinoma in patients aged 40 or older. The device is intended to assist clinical decision-making rather than serve as a standalone diagnostic or screening tool.

The FDA also required additional post-market validation in patients representative of the U.S. population. In DERM-SUCCESS, 97.1% of participants were White, while approximately 13% had Fitzpatrick skin types V or VI.

In 2024, the DermaSensor device, entered as "FDA Breakthrough Skin Cancer Device", won the Health & Biotech category of the SXSW Innovation Awards. Later that year, it was included in TIME magazine's Best Inventions of 2024 list.

The device cost approximately $25 million to develop. By January 2024, DermaSensor had raised about $27 million in venture funding. In October 2025, it raised an additional $16 million in a Series B round, bringing its total funding to $43 million.

In October 2025, DermaSensor initiated a recall involving certain units of the device after identifying a potential specification issue that could result in incorrect results or delayed referrals. The FDA classified the action as a Class II recall; nine of 343 distributed units were identified as affected.

In 2025, the device was included in Inc. magazine's Best in Innovation list.

In June 2026, DermaSensor received a Class IIb CE Mark under the European Union Medical Device Regulation, enabling commercialization in the European Economic Area. In 2026, DermaSensor received recognition from the TiE50 and Pinnacle Awards.

Commercialization

Commercialization of DermaSensor in the United States began in mid-2024. By September 2026, DermaSensor reported that the device was being used by hundreds of healthcare provider organizations and had been used to scan more than 45,000 suspicious lesions.

DermaSensor device

The DermaSensor device is a handheld instrument whose fiber-optic tip is placed on a lesion and emits short pulses of light across a range of wavelengths. Five recordings are taken at different points on the lesion within seconds. Because malignant and benign tissues differ in their cellular and subcellular structure, they scatter light differently, and the device analyzes reflected light from structures beneath the skin surface rather than relying on the visual appearance of the lesion.

The spectral data are analyzed using a machine-learning algorithm trained and validated on scans of benign and malignant lesions collected in clinical studies. The device reports one of two outputs, "Monitor" or "Investigate Further"; when the latter is displayed, an additional similarity score from 1 to 10 is provided.

DermaSensor is intended as an adjunct to clinical decision-making rather than as a standalone diagnostic tool. The FDA authorization limits its use to physicians who are not dermatologists evaluating lesions suggestive of melanoma, basal cell carcinoma or squamous cell carcinoma in patients aged 40 or older.

DermaSensor has relatively low specificity, which may result in false-positive findings and additional referrals of benign lesions. Its performance has been compared with that of Nevisense, another FDA-approved device with similarly high sensitivity and low specificity. The DERM-SUCCESS trial evaluated lesions that primary care physicians had already selected for biopsy, meaning that it did not assess the device as a general screening tool; nearly all participants were White.

The DERM-SUCCESS pivotal trial enrolled more than 1,000 patients at 22 primary care sites in the United States and Australia. Across 1,579 lesions, the device had an overall sensitivity of 95.5% and specificity of 20.7%; among patients aged 40 or older, sensitivity was 96.3%. Participating primary care physicians had a sensitivity of 83.0% in identifying malignant lesions. Its sensitivity was broadly similar across skin phototypes, although patients with darker skin types represented a relatively small proportion of the study population.

In a 2023 clinical utility study, use of the device increased the sensitivity of primary care physicians' referral decisions from 81% to 94%, while the change in management specificity from 36% to 31% was not statistically significant. In a separate 2025 reader study, the proportion of missed cancers decreased from 18.0% to 8.6%, while referral specificity decreased from 44.2% to 32.4%.

A study of patient-selected lesions found a sensitivity of 90.0% and specificity of 60.7% for DermaSensor, compared with lower sensitivity but higher specificity among unaided primary care clinicians. In DERM-ASSESS III, the device identified 95.5% of melanomas and had a specificity of 32.5% in a high-risk population of lesions biopsied by dermatologists.

A 2026 horizon-scanning assessment by Singapore's Agency for Care Effectiveness found that DermaSensor showed high sensitivity but low-to-moderate specificity across the available evidence, while its overall effects on diagnostic accuracy, management decisions and healthcare resource use remained uncertain. The assessment also noted limited representation of Asian patients in the key studies, that the key studies had been funded by DermaSensor, and that no cost-effectiveness studies had been identified.

References