Products

DermaSensor
DermaSensor Inc.
Clinical Decision Support & Reference
DermaSensor offers an FDA-cleared, AI-powered handheld device for non-invasive skin cancer evaluation, aiding primary care physicians in referral decisions for suspicious lesions.

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About DermaSensor

DermaSensor Inc. is a Miami-based medical device company at the forefront of AI-powered skin cancer detection, specifically designed to empower primary care physicians (PCPs) with advanced diagnostic capabilities. The company’s flagship product, the DermaSensor™ device, is an FDA-cleared, non-invasive, handheld tool that leverages cutting-edge optical spectroscopy and artificial intelligence to evaluate suspicious skin lesions for potential malignancy in seconds. This technology works by emitting light bursts onto a lesion and analyzing the scattered light spectra to detect properties consistent with malignancy at a cellular and subcellular level, akin to an ultrasound but using light.

The DermaSensor device provides an objective 0-10 cancer risk assessment scale, guiding physicians with ‘Investigate Further’ or ‘Monitor’ recommendations. It is indicated for use by non-dermatologist physicians to assess lesions concerning for melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC) in patients 40 years or older. Clinical studies have demonstrated that the device significantly improves PCPs’ ability to detect skin cancer, increasing management sensitivity and diagnostic sensitivity, and reducing false negative referrals. By offering rapid, accurate, and objective assessments at the point of care, DermaSensor aims to bridge the gap in dermatology access, streamline the skin exam process, and ultimately facilitate earlier detection and intervention for skin cancer, which is crucial for improved patient outcomes.

Focus Areas

Skin cancer detection AI spectroscopy primary care melanoma basal cell carcinoma squamous cell carcinoma

Business Intelligence

Key InvestorsPier 70 Ventures, Kern Venture Group, GenHenn Capital, SternAegis Ventures, Ceros Capital Markets, Miami Angels, Harmonix, Ligo Partners, Serial Stage Venture Partners, David Matlin, Chris Dewey
PartnershipsMayo Clinic, Yale University, University of North Carolina School of Medicine, SUNY Downstate Health Sciences University (for clinical studies)
TechnologyElastic Scattering Spectroscopy (ESS), AI algorithms, machine learning, optical spectroscopy, handheld device, cloud integration
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Skin Cancer Detection
FDA-cleared, non-invasive device for evaluating lesions suggestive of melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC) at the point of care.
AI-Powered Analysis
Utilizes advanced artificial intelligence algorithms, trained on over 20,000 spectral scans from thousands of diagnosed lesions, to provide objective risk assessment.
Elastic Scattering Spectroscopy (ESS)
Employs ESS technology to analyze cellular and sub-cellular features of skin lesions, providing insights beyond what is visible to the naked eye or dermatoscope.
Primary Care Focus
Specifically designed and FDA-cleared for use by non-dermatologist physicians, empowering primary care to improve skin cancer detection and referral decisions.
Rapid, Objective Results
Delivers immediate results (Investigate Further or Monitor) in seconds, streamlining the assessment process and aiding clinical decision-making.
Physician Tip

DermaSensor stands out for physicians by offering an objective, non-invasive, and rapid tool to enhance skin cancer detection in primary care settings. It significantly improves a primary care physician's (PCP) ability to evaluate suspicious lesions, with studies showing increased sensitivity for melanoma detection and a reduction in missed skin cancers. The device provides objective data on cellular and sub-cellular structures, augmenting visual inspection and dermoscopy, which can lead to more confident and appropriate referral decisions to dermatology. This is particularly valuable in addressing the existing gaps in access to dermatological care, allowing PCPs to play a more proactive role in early skin cancer identification and patient triage. Its ease of use and quick results integrate seamlessly into busy clinical workflows, ultimately aiming to improve patient outcomes through earlier detection and timely intervention.

The DermaSensor device is a handheld, wireless unit designed for point-of-care use. It features cloud-based data synchronization via a secure Wi-Fi connection for software updates and remote device functionality monitoring. While the search results do not explicitly detail direct EMR/EHR integrations, its design emphasizes seamless integration into existing clinical workflows within various practice types, including family medicine and internal medicine.

Products by DermaSensor

1 product in the directory

DermaSensor
DermaSensor Inc.
Clinical Decision Support & Reference
DermaSensor offers an FDA-cleared, AI-powered handheld device for non-invasive skin cancer evaluation, aiding primary care physicians in referral decisions for suspicious lesions.

What the Web Says

DermaSensor is a health technology company that has developed an AI-powered, handheld device designed to assist primary care physicians (PCPs) in evaluating skin lesions for potential cancer. The device uses elastic scattering spectroscopy and a machine-learning algorithm to provide objective information, aiming to improve early detection and reduce the rate of missed skin cancers. While it has received FDA clearance and shows high sensitivity in detecting various skin cancers, its low specificity means it may flag a significant number of benign lesions, potentially leading to unnecessary referrals.

Overall: Positive

Strengths

  • High sensitivity in detecting skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma.
  • Increases diagnostic and referral sensitivity for PCPs, helping them identify high-risk lesions.
  • Improves physician confidence in management decisions regarding suspicious lesions.
  • Non-invasive and easy to use, requiring minimal training.
  • Can help bridge gaps in access to dermatology by empowering PCPs.
  • Works effectively across different skin tones.

Limitations

  • Low specificity, meaning a notable percentage of benign lesions may be flagged as potentially malignant, leading to unnecessary biopsies or referrals.
  • Requires a WiFi connection to perform screenings.
  • Additional expense due to a subscription-based plan.
  • Not practical for general lesion screening due to time/steps involved.
  • Cost-effectiveness remains uncertain.
  • One employee review mentioned not being paid for work and issues with accommodating medical needs.

Based on reviews from: TIME, Dermatoscopes.com, Salary.com, HCPLive, Isomer (ACE BRIEF), EINPresswire.com, Reddit, DermaSensor (Official Website), Nature (npj Digital Medicine), Indeed.com, Zippia

Last updated: 2026-07-17

Videos

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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 received Class IIb CE Mark certification for its AI-powered skin cancer detection device, allowing commercialization across the European Economic Area and initiating a global expansion strategy, including 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
Following its CE Mark certification for Europe, DermaSensor announced a $5 million investment from a European commercial partner to accelerate market access and a feasibility study with the NHS.
2026-06
EIN Presswire
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.
2025-11
Dermatology Times
DermaSensor Increases Confidence and Accuracy in Melanoma Detection
An AI-powered handheld spectroscopy device from DermaSensor is showing promise in improving melanoma detection accuracy among primary care physicians, addressing critical gaps in early diagnosis and timely referral.
2025-11
EIN Presswire
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 fuel the commercial expansion of its FDA-cleared, non-invasive skin cancer detection solution, bringing the total investment in the company to $43 million.
2025-10
EIN Presswire
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 validated DermaSensor's Elastic Scattering Spectroscopy (ESS) device for skin cancer detection, demonstrating 96% sensitivity and a 50% reduction in missed cancer referrals by PCPs.
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 pivotal moment in digital health innovation and establishes a new regulatory precedent.
2024-06
DermaSensor Inc.
FDA Clearance Granted for First AI-Powered Medical Device to Detect All Three Common Skin Cancers
DermaSensor Inc. announced FDA clearance for its real-time, non-invasive skin cancer evaluation system, making it the first AI-powered medical device to detect all three common skin cancers for use by primary care physicians.
2024-01

Frequently Asked Questions

DermaSensor is an FDA-cleared, handheld, non-invasive device that uses Elastic Scattering Spectroscopy (ESS) and an AI algorithm to evaluate skin lesions suggestive of melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC) in patients aged 40 and above. It analyzes cellular and subcellular characteristics to provide an immediate 'Investigate Further' or 'Monitor' result, assisting primary care physicians (PCPs) in making informed referral decisions.
DermaSensor is indicated as an adjunctive tool for evaluating lesions suspicious for melanoma, BCC, and SCC, not for direct diagnosis or as a standalone screening tool. Clinical studies have shown the device to have a 96% sensitivity across all skin cancers, and it has been found to decrease missed skin cancers by half in primary care settings.
DermaSensor received FDA clearance in January 2024, becoming the first AI-powered device for skin cancer detection specifically for primary care use. It was authorized through the De Novo pathway following its Breakthrough Device designation and also holds a CE Mark, indicating its compliance with European health, safety, and environmental protection standards.
DermaSensor operates on a subscription-based commercial model, with introductory pricing options such as $199 per month for five patients or $399 per month for unlimited use. The company also offers reimbursement guidance at no cost through a partnership with TRG (The Reimbursement Group) to assist practices with coding and documentation.
DermaSensor provides on-demand customer support, e-learning courses, and comprehensive instructional materials, including Instructions For Use (IFU) and Quick Reference Guides. No formal certification is required, and the company offers supplemental educational resources and patient education materials.
Yes, DermaSensor actively forms partnerships, notably with The Reimbursement Group (TRG) to offer reimbursement assistance to its users. The company also collaborates with health systems and individual primary care practices to integrate its technology, aiming to expand access to advanced skin cancer evaluation, especially in areas with limited dermatology access.
DermaSensor is a Series B company, founded in 2009, and has demonstrated financial stability by raising a total of $60.7 million in funding, including a $16 million Series B round in October 2025. The company's long-term vision is to continue developing non-invasive tools to empower primary care physicians in skin cancer detection and improve patient outcomes.

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