- No published price for an outright purchase. Monthly rental subscription, one-year device use agreement with try-and-return option.
- Not disclosed
- Not disclosed
- —
- 2009
- US
Decision support
DermaSensor
by DermaSensor · founded 2009 · US
Handheld spectroscopy device giving primary care physicians an AI score on skin lesions already judged suspicious.
On this page
49/100
Editorial rating 3.5 / 5
- Regulatory & Compliance12/22
FDA cleared (1 K-number on record)
- Clinical Integration0/11.6
No EHR integrations listed
- Evidence Strength19.2/30
3 peer-reviewed papers
- Vendor & Market9/18
Founded 2009 (17 years)
- Sentiment & Transparency1.3/2.5
Pricing on request, no public amounts
▸ Show all 11 dimensions▾ Hide dimension detail
- FDA clearance12/12
FDA cleared (1 K-number on record)
- HIPAA / SOC2 / BAA0/10
No public HIPAA/SOC2/BAA attestation
- EHR integrations (count)0/6
No EHR integrations listed
- Top-3 EHR coverage (Epic / Oracle / Athena)0/5
None of the top-3 EHRs covered
- Bidirectional write-back0/1
No bidirectional write-back documented
- Peer-reviewed papers15/21
3 peer-reviewed papers
- RCT / meta-analysis / systematic review5/9
1 observational study (no RCT)
- Funding & adoption signal3/12
Seed-stage or unfunded
- Years in market6/6
Founded 2009 (17 years)
- Pricing transparency1/3
Pricing on request, no public amounts
Handheld spectroscopy device giving primary care physicians an AI score on skin lesions already judged suspicious.
No published price for an outright purchase. Monthly rental subscription, one-year device use agreement with try-and-return option.
Evidence record
De NovoDEN230008 (opens in new tab)January 12, 2024
DermaSensor
3 studies on PubMed: 2 other, 1 observational, published 2024 to 2025. Read the literature summary
- Score computed November 2, 2026, method 1.2.0
- Review written November 2, 2026
MedAI Verdict, DermaSensor record, https://medaiverdict.com/tools/dermasensor, version November 2, 2026
Bottom line
The FDA granted DermaSensor a De Novo, DEN230008, on January 12, 2024. The handheld probe is held against a lesion a physician already finds suspicious and returns "Monitor" or "Investigate Further" with a score from 1 to 10. It fits a primary care physician deciding whether to refer a lesion. The vendor's own data show that many benign lesions still receive "Investigate Further", and the vendor says the device is not a screening tool and not for consumer use.
What did the FDA decide?
DEN230008 was decided on January 12, 2024 for Dermasensor, Inc., product code QZS, under 21 CFR 878.1830. The classification name is "software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer". It is a De Novo classification, so no 510(k) K number exists. The vendor describes use by non-dermatologist physicians on patients 40 and older, and says the result should not be the sole diagnostic criterion.
How does the technology work?
The vendor's technology page describes five spectral recordings per lesion with a xenon lamp across 47 wavelengths, read by a locked algorithm that the vendor says was developed and validated on over 20,000 scans from more than 4,000 malignant and benign lesions. Positive predictive value in vendor data runs from 6% at a score of 1 to 61% at a score of 10.
The FAQ says EHR integration will come "over time". For now a report is uploaded or the result entered manually.
What do the studies report?
The vendor's evidence page presents the figures. In DERM-SUCCESS, a multi-reader, multi-case study in the Journal of Primary Care and Community Health (2025, PMID 40448353), sensitivity was 96% and negative predictive value 97% for a "Monitor" result. Overall specificity was 33% in DERM-ASSESS III, a multicenter prospective blinded melanoma study in JAAD International (2024, PMID 38371666). A prospective evaluation of patient-identified lesions at UPMC (JAAD International 2025, PMID 41048338) is called by the vendor the first independent investigator-initiated US study, and it reports specificity of 9.4% at the lowest cut point.
Company and rental terms
DermaSensor, Inc. is based in Miami and was founded in 2009 by Dr Maurice Ferre and Christopher Dewey. A $16 million Series B on October 2, 2025 brought total investment to $43 million, with new investors Pier 70 Ventures, Kern Venture Group and GenHenn Capital. The vendor claims use in "hundreds of healthcare institutions".
It rents the device by the month under a one-year agreement with a try-and-return option, training included. An outright purchase price is unpublished, no per-scan fee is listed and the FAQ says a dedicated CPT code has not been established.
The verdict
A primary care physician weighing whether to refer is the intended user. A practice whose patients are mostly under 40 falls outside the described use. In the vendor's data, specificity of 9.4% to 33% means many benign lesions receive "Investigate Further".
Editorial review last generated November 2, 2026. Synthesized from clinician sentiment, peer-reviewed coverage, and our editorial silo picks. Refined by hand where vendor facts change.
What it costs
All tiers are custom-quoted. The vendor does not publish per-provider list pricing.
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | Not stated | Not stated | No published price for an outright purchase. Monthly rental subscription, one-year device use agreement with try-and-return option. |
Source: vendor pricing page. Last checked November 2, 2026.
What deploys cleanly
Carries FDA De Novo per vendor documentation. Independent attestation review is the buyer's responsibility before clinical deployment.
Who builds it
DermaSensor (DermaSensor) was founded in 2009 in US, putting it 17 years into market.
What the literature says
3 peer-reviewed studies indexed on PubMed evaluate DermaSensor in clinical contexts. The most relevant are shown below, ranked by editorial relevance score combining title match, study design, recency, and journal tier.
- Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA. (opens in new tab)
- Venkatesh KP, Kadakia KT, Gilbert S· NPJ Digit Med· 2024
- The U.S. Food and Drug Administration’s (FDA) recent authorization of DermaSensor, an AI-enabled device for skin cancer detection in primary care, marks a pivotal moment in digital health innovation. Clinically, the authorization of the first AI-enabled device for use by non-specialists for detecting skin cancer reinforces the feasibility of digital health technologies to bridge gaps in access and expertise in medical practice. The authorization also establishes a new regulatory precedent for FDA authorization of medical devices incorporating AI and machine learning (ML) technologies w…
- Enhancing Diagnostic Precision in Primary Care: A Multireader Multicase (MRMC) Study of an AI-Powered Handheld Elastic Scattering Spectroscopy Device for Informed Referral Decisions in Melanoma Evaluation. (opens in new tab)
- Seiverling EV, Shah A, Weinstock MA, et al.· J Clin Aesthet Dermatol· 2025
- Skin cancer is the most common cancer faced by adults in the United States. Melanoma, while a less common subtype of skin cancer compared to basal cell and squamous cell carcinomas, is associated with greater rates of metastases, mortality, and morbidity, and its rate of incidence is projected to increase. Primary care physicians (PCPs) can play an important role in skin cancer detection and in the decision to refer a patient to a dermatologist. Technologies such as the elastic scattering spectroscopy (ESS) device (DermaSensor, Inc.), a handheld, noninvasive assistive tool, may help in the ev…
- Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer. (opens in new tab)
- Merry SP, Croghan IT, Dukes KA, et al.· J Prim Care Community Health· 2025
- To evaluate the performance of noninvasive, elastic scattering spectroscopy, algorithm-powered device (DermaSensor) to detect melanoma and basal and squamous cell cancers in the primary care setting. DERM-SUCCESS, a blinded, prospective, multicenter pivotal study, enrolled adult patients between August 17, 2020, and December 9, 2021, with lesions that their primary care physicians (PCPs) suspected of skin cancer at clinics in the US (n = 18) and Australia (n = 4). These lesions were assessed by PCPs and scanned with the DermaSensor device. Biopsy specimens were col…
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