DermaSensor AI Diagnostic Device: Advanced AI Diagnostic Device Technology

What Is DermaSensor?

Skin cancer is the most common cancer in the United States, affecting approximately one in five Americans during their lifetime. Early detection is the single most important factor in successful treatment — when caught early, the five-year survival rate for melanoma exceeds 99 percent. Yet many skin cancers go undetected for months or years, particularly when patients see providers who are not dermatology specialists.

DermaSensor is the first FDA-approved AI-enabled medical device designed specifically to help non-dermatologist physicians assess suspicious skin lesions. Cleared by the FDA in January 2024, this handheld device uses elastic scattering spectroscopy (ESS) — a light-based technology — to analyze the cellular structure of skin lesions and provide a risk score that helps determine whether a lesion should be biopsied or referred for specialist evaluation.

The significance of this device lies not in replacing dermatologists, but in expanding the reach of quality skin cancer screening to primary care settings, urgent care clinics, and other clinical environments where patients may present with concerning lesions but a dermatologist is not immediately available.

How DermaSensor Works

DermaSensor employs a technology called elastic scattering spectroscopy, which works by shining specific wavelengths of light into the skin and measuring how that light interacts with cellular structures as it reflects back.

The physics behind it. When light enters the skin, it interacts with various cellular components — nuclei, cell membranes, collagen fibers, and other structures. Cancerous and precancerous cells differ from normal cells in their size, shape, density, and internal organization. These structural differences cause light to scatter in distinct, measurable patterns. The DermaSensor device detects these scattering patterns and uses AI algorithms trained on thousands of lesion assessments to interpret them.

The scoring system. After a brief, painless scan (which takes just seconds), the device generates a score on a 1 to 10 scale. Higher scores indicate a greater likelihood that the lesion has features associated with malignancy. This score is not a diagnosis — it is a risk assessment that helps the provider decide whether the lesion warrants biopsy, referral to a dermatologist, or monitoring.

What the device detects. DermaSensor is designed to assess lesions for features associated with the three most common types of skin cancer:

• Melanoma — The most dangerous form of skin cancer, arising from melanocytes (pigment-producing cells)
• Basal cell carcinoma (BCC) — The most common skin cancer, typically appearing as a pearly bump or non-healing sore
• Squamous cell carcinoma (SCC) — The second most common skin cancer, often appearing as a scaly patch or firm red bump

Clinical Performance and Evidence

DermaSensor has undergone clinical evaluation in multiple studies involving thousands of skin lesions. The key performance metrics that define its clinical utility are sensitivity and specificity.

Sensitivity: 96.5%

Sensitivity measures the device's ability to correctly identify lesions that are truly cancerous or precancerous. A sensitivity of 96.5% means that out of every 100 malignant lesions scanned, the device correctly flags approximately 97 of them. This high sensitivity is critical in a screening tool — the primary goal is to avoid missing cancers.

Specificity: 20.7%

Specificity measures the device's ability to correctly identify lesions that are benign. A specificity of 20.7% means that out of every 100 benign lesions scanned, approximately 21 are correctly identified as low risk, while approximately 79 are flagged as potentially concerning.

Understanding the Tradeoff

The combination of high sensitivity and low specificity is a deliberate design choice for a screening tool. In skin cancer screening, the consequences of a missed cancer (a false negative) are potentially life-threatening, while the consequence of a false alarm (a false positive) is an unnecessary but harmless biopsy or referral. The device is intentionally calibrated to err on the side of caution.

This means that a high DermaSensor score does not necessarily mean cancer is present — it means the lesion has features that warrant further evaluation. Conversely, a low score provides meaningful reassurance that the lesion is unlikely to be malignant.

For context, studies have shown that primary care physicians without specialized dermatology training correctly identify malignant lesions at rates significantly below 96.5%. DermaSensor substantially improves the accuracy of skin cancer screening in non-dermatology settings.

Who Benefits From DermaSensor Screening?

Patients

DermaSensor is particularly valuable for patients who:

• Have a suspicious mole, spot, or lesion and want an initial assessment
• Are at higher risk for skin cancer due to fair skin, sun exposure history, family history, or a personal history of previous skin cancers
• Live in areas with limited access to dermatologists (dermatology is one of the most undersupplied specialties, with wait times for new patients often exceeding several weeks)
• Want an objective, technology-assisted evaluation to complement their provider's clinical judgment
• Are monitoring multiple moles and want to track changes with a quantifiable score

Healthcare Providers

For primary care physicians, nurse practitioners, and physician assistants, DermaSensor provides a valuable clinical decision support tool. It can help providers:

• Triage skin lesions more confidently, reducing uncertainty about whether to biopsy or refer
• Identify concerning lesions that might otherwise be monitored, potentially catching cancers earlier
• Provide patients with objective data to support clinical recommendations
• Reduce the burden of referrals to dermatology for clearly benign lesions (when the device returns a low score)

What to Expect During a DermaSensor Assessment

A DermaSensor evaluation is quick, painless, and non-invasive.

Before the assessment, your provider will identify the lesion or lesions to be evaluated. This may occur during a routine physical exam, a skin check, or a visit prompted by a specific concern. No special preparation is needed.

During the assessment, the provider places the DermaSensor device directly on the skin over the lesion. The device emits a brief pulse of light and analyzes the returning signal. The entire scan takes only a few seconds per lesion. There is no pain, no incision, no injection, and no anesthesia required.

After the assessment, the device provides its risk score, which the provider interprets in the context of your clinical picture. Based on the score and their clinical evaluation, your provider will recommend one of the following:

• Monitoring — For low-risk scores on lesions that appear clinically benign. Follow-up may be recommended at a specific interval.
• Biopsy — For lesions with elevated scores or concerning clinical features. A biopsy involves removing a small tissue sample for microscopic analysis by a pathologist and is the definitive way to diagnose or rule out skin cancer.
• Referral to dermatology — For lesions that warrant specialist evaluation, either for biopsy or for additional assessment with dermoscopy and other advanced diagnostic tools.

The assessment adds only a few minutes to your appointment and can provide significant peace of mind or prompt timely action when needed.

DermaSensor in the Context of Comprehensive Skin Care

DermaSensor is a screening tool — an important first step in skin cancer detection, not a complete skin surveillance program. Comprehensive skin health monitoring typically includes:

Regular professional skin exams. The American Academy of Dermatology recommends annual full-body skin exams for patients at average risk, with more frequent exams for those at higher risk. These exams should ideally be performed by a board-certified dermatologist who can evaluate lesions using clinical expertise, dermoscopy, and other advanced techniques.

Self-examination. Monthly skin self-exams remain an important part of early detection. Knowing what your moles and marks look like — and noticing when something changes — often leads to the earliest detection of concerning lesions. The ABCDE criteria (Asymmetry, Border irregularity, Color variation, Diameter greater than 6mm, Evolving) remain a useful framework for self-assessment.

AI-powered skin analysis. As discussed in our article on AI-powered skin diagnostics, advanced imaging and AI analysis can provide comprehensive skin mapping and longitudinal tracking — monitoring changes in individual lesions over time with a precision that complements both clinical examination and devices like DermaSensor.

Sun protection. Prevention remains the most important strategy. Consistent use of broad-spectrum SPF 30+ sunscreen, protective clothing, and sun avoidance during peak hours significantly reduces skin cancer risk.

Limitations and Important Considerations

Understanding what DermaSensor can and cannot do is essential for appropriate use.

It is not a diagnostic device. DermaSensor does not diagnose skin cancer. It provides a risk assessment that helps guide clinical decision-making. Only a biopsy with pathological analysis can definitively diagnose or rule out skin cancer.

It does not replace dermatological evaluation. While DermaSensor improves screening accuracy for non-specialists, it does not replicate the comprehensive evaluation that a board-certified dermatologist provides — including dermoscopy, clinical pattern recognition, and the ability to perform biopsies on the spot.

Lesion type limitations. The device is designed for certain types of skin lesions and may not be appropriate for all skin concerns. Very small lesions, lesions in certain anatomical locations, or lesions with features that fall outside the device's training parameters may not be suitable for assessment.

The false positive rate is significant. Given the 20.7% specificity, most lesions flagged by the device will ultimately prove to be benign. Patients should understand this before the assessment to avoid unnecessary anxiety.

Why Choose Allure MD for Skin Cancer Screening

At Allure MD in Newport Beach, skin cancer screening is performed within the context of a comprehensive dermatology practice led by Dr. Rosing — a Stanford-trained, FACS-certified physician with over 14 years of experience. The practice combines clinical expertise with advanced diagnostic technology, including AI-powered tools, to provide thorough, accurate skin evaluations.

When a suspicious lesion is identified, the full range of next steps — from biopsy to specialist consultation to treatment — is available within the same practice. This continuity of care means that patients do not need to navigate between multiple providers or wait weeks for a referral.

If you have a concerning skin lesion, are due for a skin cancer screening, or want to establish a baseline skin health assessment, contact Allure MD at (949) 706-7874 to schedule your appointment.