BETA
Miami-based developer of a handheld spectroscopy and AI device that helps physicians assess suspicious skin lesions and decide whether to refer patients to dermatology.
DermaSensor is a privately held medical device company founded in 2009 and headquartered in Miami, Florida, United States. CEO and co-founder Cody Simmons leads the company, which combines elastic scattering spectroscopy with a locked AI algorithm to assess suspicious skin lesions at the point of care.
Its prescription DermaSensor device received FDA De Novo authorization in January 2024 and launched in the U.S. in May 2024. The U.S. indication is limited to patients aged 40 and older and use by non-dermatologist physicians alongside clinical assessment. It supports referral decisions for lesions already considered suspicious; it is not a screening tool or a standalone cancer diagnosis.
The company reported a $16 million Series B in October 2025 and further institutional and community financing in 2026. Its SEC-filed, independently reviewed financial statements report $418,630 in 2025 revenue. U.S. commercialization includes procurement, sales and VA reseller channels; a September 2026 German launch followed a company-reported Class IIb CE mark under EU MDR.
DermaSensor was granted De Novo classification under DEN230008 on January 12, 2024. Its U.S. indication is adjunctive evaluation of already-suspicious lesions in patients aged 40 or older by non-dermatologist physicians to assist referral decisions. It is not a screening test or a standalone diagnosis of skin cancer. [7][2][9][10][19]
FDA lists an open recall for specified Model 10101 units running software 3.0.2 (Z-0583-2026), initiated October 13, 2025. The reported component/specification issue could cause incorrect results or delayed referral; it does not establish that all DermaSensor units are affected. [8]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
| Recalled product / record | Initiated | Source |
|---|---|---|
| October 13, 2025 | [8] |
Documented commercial product families.
Prescription handheld device measures elastic light scattering from suspicious skin lesions and uses a locked machine-learning algorithm to provide referral-support output. [12][2][3][15][17]
FDA De Novo grantedU.S. commercial launch in May 2024; German launch through ContraCare announced September 2026.
Publicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| Henry Schein Medical [16] | United States | DermaSensor device |
| MedTech MedCare (MTMC) [16] | United States — Texas implementation; expansion planned | DermaSensor device |
| Medical Place [16] | United States — Department of Veterans Affairs channel | DermaSensor device |
| ContraCare GmbH / DERMALYTICA [17] | Germany, Austria and Switzerland | DermaSensor device |
Sources checked October 17, 2026.
DermaSensor announced launch through ContraCare’s DERMALYTICA division. The distribution agreement covers Germany, Austria and Switzerland; the announced initial launch was Germany. [17]
Company reported $4 million closed in a Series B extension and more than $1 million raised through its ongoing Wefunder community round. [25]
Company named Henry Schein Medical, MedTech MedCare and VA-channel reseller Medical Place; a fourth healthcare partner was unnamed. [16]
Company reported an EU MDR Class IIb CE mark and an NHS feasibility study for GP use. Neither independent certificate validation nor nationwide NHS procurement is established here. [10]
Company announced a $16 million Series B to expand commercialization, with existing investors and new venture participants. [14]
FDA granted DEN230008 for the prescription skin lesion evaluation adjunct, with specified user, age and intended-use restrictions. [2]
Company history places the U.S. launch in May 2024. Exact launch day is not established. [13]
FDA review describes a prospective, blinded, multicenter study with 1,005 participants and 1,579 lesions in the effectiveness population at 22 sites. Most participants were White; results do not establish equivalent performance in every subgroup. [3]
Maurice Ferre and Christopher Dewey founded DermaSensor around elastic scattering spectroscopy technology. [13]
Accessed 10/29/2026