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DermaSensor

by DermaSensor Inc. · Based in United States → — Skin Cancer Evaluation. Simplified.

Dermatology Family Medicine Internal Medicine

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Monthly rental basis, with introductory pricing tiers.

Regulatory Status Disclosed

Overview

DermaSensor Inc. is a Miami-based connected medical device company dedicated to empowering healthcare professionals with clinically proven solutions for efficient skin cancer detection. The company’s flagship product, the DermaSensor™ device, is an FDA-cleared, AI-powered, handheld tool that utilizes elastic scattering spectroscopy (ESS) to non-invasively evaluate suspicious skin lesions. It provides immediate, objective results to assist non-dermatologist physicians, primarily primary care physicians (PCPs), in making informed referral decisions for lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma. The device aims to improve early detection rates, increase access to vital healthcare, and ultimately save lives by providing objective data beyond what is visible to the naked eye.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

AI-powered skin cancer detection
Elastic Scattering Spectroscopy (ESS) technology
Non-invasive, handheld device
Real-time, objective results ('Investigate Further' or 'Monitor')
96% sensitivity for detecting melanoma, basal cell carcinoma, and squamous cell carcinoma
Wireless and ergonomically designed
Cloud integration for data storage
Automatic software updates
Reimbursement assistance available
Physician finder to locate clinics using DermaSensor

Use Cases

Assisting primary care physicians (PCPs) in evaluating suspicious skin lesions
Improving early detection of melanoma, basal cell carcinoma, and squamous cell carcinoma
Supporting referral decisions to dermatologists
Enhancing clinical confidence in skin cancer detection
Streamlining skin cancer assessment workflow in clinical settings
Providing objective data beyond visual assessment

What Physicians Need to Know

Evidence Base

DermaSensor utilizes Elastic Scattering Spectroscopy (ESS) combined with artificial intelligence (AI) algorithms. The algorithms are trained on thousands of diagnosed lesions. ESS technology has been evaluated in over 30 peer-reviewed publications. The device received FDA authorization based on evidence from three key studies: a pivotal trial (DERM-SUCCESS), a supplemental melanoma validation study (DERM-ASSESS III), and a clinical utility study. It is FDA cleared and CE-Marked.

Clinical Validation Studies

Multiple studies support DermaSensor's effectiveness:

**DERM-SUCCESS Pivotal Study:** Evaluated 1,579 lesions from 1,005 patients across 22 primary care centers. The device demonstrated 95.5% sensitivity (superior to PCPs' 83.0%), a Negative Predictive Value (NPV) of 96.6%, and was non-inferior to dermatologists' sensitivity of 90%. Specificity was 20.7%.
**DERM-ASSESS III Prospective Melanoma Validation Study:** Included 311 patients with 440 biopsied lesions (88 melanomas) from 10 dermatology centers. It showed 96% device sensitivity for melanoma (91% for all high-risk melanocytic lesions) and a melanoma NPV of 98%.
**Clinical Utility Study:** Involved 108 PCPs and over 10,000 lesion assessments. PCP use of the device significantly improved management sensitivity (91.4% vs. 82.0%) and diagnostic sensitivity (81.7% vs. 71.1%), and halved false negative referrals (from 18.0% to 8.6%).
**PATIENT-SELECT Study:** Found a device sensitivity of 90.0% and an NPV of 98.9% for detecting skin cancer, compared to PCPs' sensitivity of 40.0% in the study.

The device is indicated for use by non-dermatologist physicians to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above, assisting in referral decisions to a dermatologist.

Alert Fatigue Management

DermaSensor provides two clear outputs: 'Investigate Further' or 'Monitor'. For 'Investigate Further' results, a score from 1 to 10 is provided, indicating the degree of spectral similarity to malignant lesions. This tiered risk assessment helps clinicians prioritize and manage referrals, potentially mitigating alert fatigue by offering a nuanced view beyond a simple positive/negative.

Override Rate Data

Clinical utility studies indicate that device assistance significantly improved diagnostic sensitivity and referral sensitivity for PCPs. Specifically, PCP false negative referrals decreased by half (from 18.0% to 8.6%) with device use, suggesting a high rate of physician adherence to the device's 'Investigate Further' recommendation for suspicious lesions. While diagnostic and referral specificity slightly declined, overall clinical performance improved. Physicians' confidence in management decisions also increased from 36.8% to 53.4% with DermaSensor support.

Guideline Update Frequency

The AI algorithm used by DermaSensor is locked in accordance with FDA requirements. The company plans to revalidate and periodically update the algorithm approximately every couple of years, which necessitates resubmission to the FDA for clearance.

Clinical Workflow Integration

The device is designed for real-time, point-of-care use by non-dermatologist physicians in clinical settings. It provides immediate results ('Investigate Further' or 'Monitor') on a handheld device after taking five non-invasive spectral recordings, aiming to integrate seamlessly without disrupting existing workflows. The process is quick and simple, enhancing efficiency for primary care physicians. Results can be exported as a PDF from a web portal for attachment to the patient's EHR.

Decision Audit Trail

DermaSensor offers cloud storage for device results as part of its monthly rental benefits. Additionally, users can log into a web portal to export a PDF of device results, which can then be attached to the patient's Electronic Health Record (EHR), creating a digital audit trail of the decision support provided.

Physician Tip

DermaSensor is an adjunctive tool; always use it in conjunction with your comprehensive clinical assessment, including visual analysis of the lesion. It is intended for lesions already deemed suspicious for skin cancer, not as a general screening device. Leverage the 'Investigate Further' or 'Monitor' output, along with the 1-10 risk score for 'Investigate Further' results, to enhance your confidence in referral decisions and prioritize high-risk patients. Be mindful of its lower specificity, which may lead to more referrals, but recognize the significant improvement in diagnostic and management sensitivity it offers, helping to catch more cancers early.

DermaSensor is a standalone handheld device providing real-time, point-of-care results. While direct, automated EHR integration is not explicitly detailed as a standard feature, the system supports exporting device results as a PDF from a web portal for manual attachment to patient EHRs. The company is actively exploring and developing future enhancements, including advanced algorithms and a next-generation device with a camera, which may lead to more direct integration capabilities. Seamless integration into primary care workflows is a key focus for the device's success.

At a glance

Pricing Monthly rental basis, with introductory pricing tiers.

Deployment Handheld Device With A Wireless Charging Dock; Software Updates Are Delivered Remotely Via Secure Wi Fi Connection.

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Details

Category	Clinical Decision Support & Reference, Dermatology AI
Pricing	Monthly rental basis, with introductory pricing tiers. — Introductory: $199/month for 5 patients; $399/month for unlimited use; 90-day risk-free program.
Deployment	Handheld device with a wireless charging dock; software updates are delivered remotely via secure Wi-Fi connection.
Compliance
BAA Available	Unknown AI-estimated
HIPAA Compliant	Unknown AI-estimated
FDA Status	1 AI-estimated The DermaSensor device received FDA clearance on January 12, 2024 (De Novo DEN230008). It is indicated for use to evaluate skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged 40 and above to assist in the decision regarding referral to a dermatologist. It is intended for use by physicians who are not dermatologists and should be used in conjunction with clinical assessment, not as a standalone diagnostic or screening tool.
Integrations
EHR	Not specified
Specialties	Dermatology, Family Medicine, Internal Medicine

What the Web Says

DermaSensor is an AI-powered, handheld device designed to assist primary care physicians (PCPs) in detecting skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma. It uses elastic scattering spectroscopy (ESS) to analyze skin lesions and provides an immediate, objective risk assessment. The device has received FDA clearance, and studies indicate it significantly improves PCPs' ability to identify and appropriately refer suspicious lesions, thereby reducing missed cancer referrals.

Overall: Positive

Strengths

High sensitivity in detecting skin cancers (95.5% to 97%), including melanoma, BCC, and SCC.
Significantly improves primary care physicians' diagnostic accuracy and confidence in evaluating skin lesions.
Reduces the rate of missed skin cancer referrals by PCPs (up to 50%).
Provides objective, real-time results, augmenting subjective visual assessments.
Non-invasive and easy to use, requiring minimal training.
FDA-cleared for use by physicians who are not dermatologists.

Limitations

Low to moderate specificity (20.7% to 33%), which may lead to a higher number of false positives and potentially unnecessary referrals or biopsies.
Additional expense, with a subscription-based plan that may not be practical for general lesion screening due to cost and time/steps involved.
Requires a WiFi connection to perform.
Cost-effectiveness remains uncertain, especially in areas with lower skin cancer burden.
Key limitations of the evidence include low representation of the Asian population in studies and potential funding bias.

Based on reviews from: WJTV.com (Press Release), DermaSensor.com, The Brink (Boston University), npj Digital Medicine, Isomer (ACE Brief), Chief Healthcare Executive, HCPLive, EINPresswire.com, Capterra, Reddit, Dermatoscopes.com, Refresh Miami, TIME, YouTube (DermaSensor), PMC (Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer), PracticalDermatology

Last updated: 2026-07-20

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Press & Coverage

Business Wire

DermaSensor Announces Class IIb CE Mark and Collaboration with NHS, Marking the Beginning of Its Global Expansion

DermaSensor announced it received Class IIb CE Mark certification for its handheld skin cancer assessment device, allowing sales in the European Economic Area and initiating its international growth strategy. The company also announced a feasibility study with the UK's National Health Service.

2026-06

Refresh Miami

DermaSensor is expanding internationally with its skin-cancer detection device, receives $5M investment - Refresh Miami

DermaSensor, a Miami-based health technology company, is expanding into Europe after securing Class IIb CE Mark certification for its AI-powered skin cancer detection device. This expansion is supported by a $5 million investment from a European commercial partner and includes a new feasibility study with the United Kingdom's National Health Service.

2026-06

DermaSensor Inc.

Two New Studies Show DermaSensoru2122 Devices' Consistent Performance and Improvements to Physicians' Melanoma Detection

Newly published studies in the American Academy of Dermatology and the Journal of Clinical and Aesthetic Dermatology highlight the consistent performance and clinical benefits of the DermaSensor device, an FDA-cleared, AI-powered solution for evaluating suspicious skin lesions. These studies found that the device has 96% sensitivity and can reduce missed skin cancers by half.

2025-11

DermaSensor Inc.

Published FDA Pivotal Studies Find DermaSensor has 96% Sensitivity and Cuts Physician's Missed Skin Cancers by Half

Two pivotal studies published in the Journal of Primary Care and Community Health validate DermaSensor's Elastic Scattering Spectroscopy (ESS) device for skin cancer detection in primary care, demonstrating 96% sensitivity and a 50% reduction in missed cancer referrals by physicians.

2025-06

DermaSensor Inc.

DermaSensor Secures $16M to Scale AI-Powered Skin Cancer Detection in Primary Care

DermaSensor Inc. announced it has raised $16 million in Series B funding to expand the commercialization of its FDA-cleared, non-invasive skin cancer detection solution. This funding brings the total investment in the company to $43 million.

2025-10

Dermatology Times

DermaSensor device improves skin cancer detection in primary care settings, studies find

Two newly published FDA pivotal studies indicate that DermaSensor's handheld spectroscopy device significantly enhances primary care physicians' ability to detect and refer skin cancers. The device demonstrated 96% sensitivity and a 97% negative predictive value for skin cancer detection.

2025-06

Nature Medicine

Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA

The FDA's authorization of DermaSensor, the first AI-enabled medical device for skin cancer detection in primary care, marks a significant moment in digital health innovation. This article examines the clinical evidence and regulatory implications of this breakthrough.

2024-06

DermaSensor Inc.

FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers (Melanoma, Basal Cell Carcinoma and Squamous Cell Carcinoma)

DermaSensor Inc. announced FDA clearance for its real-time, non-invasive skin cancer evaluation system, making it the first AI-powered medical device for primary care physicians to detect all three common skin cancers.

2024-01

Videos

Product demos, reviews, and walkthroughs for DermaSensor.

Introducing DermaSensor - Americau2019s First Automated Skin Cancer Detection Device for Physicians

Unveiling the Future of Skin Cancer Care: The DermaSensor Story

Dermasensor - Using AI Technology to Detect Skin Cancer

View all on YouTube

Frequently Asked Questions

What are the regulatory clearances for DermaSensor, and how does it ensure patient data privacy and security?

DermaSensor received FDA authorization on January 17, 2024, as the first AI-enabled medical device for skin cancer detection in primary care, indicated for non-dermatologist physicians to evaluate melanoma, basal cell carcinoma, and squamous cell carcinoma in patients aged 40 and above. The company states it has implemented measures to maintain the confidentiality of Personal Data and that its platform is designed with HIPAA compliance in mind, utilizing encryption and secure protocols to protect patient information.

How does DermaSensor integrate into a typical clinical workflow, and what level of training is required for its effective use?

DermaSensor is a handheld device that uses Elastic Scattering Spectroscopy (ESS) and AI to provide an immediate 'Investigate Further' or 'Monitor' result for suspicious lesions, serving as an adjunctive tool to clinical assessment. No specific certification is required; instruction on proper usage and handling is provided through the Instructions For Use and supplemental educational materials.

What are the known limitations of DermaSensor's diagnostic capabilities, particularly concerning different skin types or lesion characteristics?

DermaSensor is an adjunctive tool and not intended for direct diagnosis, screening, or use on previously biopsied, recurrent, or metastatic lesions, scars, tattoos, or certain anatomical sites like palms or genitals. While some studies suggest similar sensitivity across Fitzpatrick skin types, the pivotal trial predominantly included White patients, leading the FDA to require post-market performance testing in underrepresented populations due to potential algorithmic bias.

How does DermaSensor's AI address potential biases in its training data, and what level of interpretability does it offer for its risk assessments?

The AI algorithm within DermaSensor is locked per FDA requirements, and while developers aim to mitigate bias through diverse datasets, concerns have been raised regarding the underrepresentation of darker skin tones in dermatology AI training data. The device provides a risk score or classification, but the underlying 'reasoning' of the AI's spectral analysis is not fully transparent, requiring physicians to integrate the output with their clinical expertise.

How does DermaSensor compare to traditional dermatoscopy or other AI-powered diagnostic aids, and what are its key advantages?

DermaSensor is an assistive tool designed to augment, not replace, physician expertise or dermatoscopy, particularly for non-dermatologist physicians. It offers high sensitivity in detecting common skin cancers, which can increase a primary care physician's diagnostic and referral sensitivity, but it has a lower specificity compared to traditional methods, potentially leading to more referrals for benign lesions.

What is the cost of DermaSensor, and what are the current reimbursement pathways for its use in clinical practice?

DermaSensor is available on a monthly rental basis, with introductory pricing options such as $199 per month for 5 patients or $399 per month for unlimited use. DermaSensor offers reimbursement assistance, and its services may be reported under unlisted CPT codes (96999 or 17999), though coverage can vary as some payers may consider it experimental or investigational.

Does using DermaSensor alter a physician's medical-legal liability in diagnosing skin cancer, and how does it impact the physician's ultimate diagnostic responsibility?

DermaSensor is an adjunctive tool intended to assist in referral decisions, and the ultimate diagnostic responsibility for skin cancer remains with the physician. Physicians are expected to use their professional judgment, interpret all clinical information, and make final decisions, as the device is not intended to be used as the sole diagnostic criterion or to confirm a clinical diagnosis.