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“This is a transformative milestone for DermaSensor and an important step in our mission to improve access to skin cancer detection globally,” said Cody Simmons, Co-Founder and CEO of DermaSensor. “We are the first and only automated device authorized by the FDA for detection of all three common skin cancers as well as the first and only automated skin cancer tool that can be used by physicians who are not already experts in dermatology. While many companies have tried, no such tools that are currently available in Europe have been able to achieve approval in the US, given the FDA’s high bar for clinical evidence. We are excited to now have the regulatory authorization to make our industry-leading product available to European Healthcare Providers (HCP’s) and their patients.”

DermaSensor’s handheld device uses spectroscopy and artificial intelligence to test suspicious skin lesions for cancer in real time at the point of care. The DermaSensor solution is CE marked for use by qualified healthcare professionals to inform whether suspicious lesions merit further clinical care (e.g. refer to dermatology, biopsy). The device’s performance and benefits have been consistently demonstrated across nine published studies conducted with over 40 clinical study sites and hundreds of clinicians in both the primary care and dermatology settings. The device has also recently received dozens of prestigious awards and recognitions, including TIME’s 2024 Best Invention List and Inc Magazine’s 2025 Best in Innovation alongside companies such as Anthropic and Nvidia.

Skin cancer remains one of the most common cancers worldwide, with growing demand for tech-enabled solutions that can help improve access to early detection. The CE Mark certification positions DermaSensor to pursue commercial opportunities with healthcare systems, physician networks, and distribution partners throughout Europe and other international markets that recognize CE Mark standards.

The company is also today announcing a feasibility study in collaboration with the National Health Service (NHS), focused on evaluating the impact of AI-assisted skin cancer assessment when used by GPs within the NHS setting. Additional details regarding the collaboration will be announced in the coming months.

DermaSensor also recently entered into a strategic commercial partnership with a large European distributor to support commercialization efforts and accelerate market access within certain of Europe’s largest healthcare markets. This commercial partner invested $5 million in DermaSensor’s recent Series B financing. The company is actively seeking additional commercial partners, leading healthcare systems, and physician thought leaders as the company aims to gain broad adoption in Europe as it has already done in the US with hundreds of healthcare provider institutions that are collectively using the devices on thousands of patients a month.

If you are interested in being a potential partner with DermaSensor, please provide information online through DermaSensor’s website. 

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is FDA Cleared (De Novo), CE Marked, and is currently available for sale in the U.S.

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Addressing a Growing Public Health Issue

Skin cancer remains the most common cancer in the U.S., affecting millions of Americans each year, with melanoma carrying the highest risk of mortality. Limited access to dermatologists increases PCPs’ responsibility to evaluate lesions suggestive of skin cancer [2,3].

“Primary care physicians are often the first to encounter suspicious skin lesions, yet many lack significant training and confidence in dermatologic assessment,” said Dr. Dan Siegel, Clinical Professor of Dermatology at SUNY Downstate and former President of the American Academy of Dermatology. “This study demonstrates how the non-invasive DermaSensor technology can significantly enhance diagnostic accuracy and empower clinicians to make more informed, confident decisions for their patients” [1,4].

Overview and Results of the Clinical Studies

The JAAD International study was conducted at UPMC and was the first investigator-initiated study ever conducted with DermaSensor in the United States. This independent, prospective study evaluated patients’ lesions of concern among 150 dermatology patients and found [8]:

• Sensitivity and specificity of the device were 100% and 9.4%, respectively, using Investigate Further vs Monitor as the cutpoint for positive vs negative. The publication also reported that sensitivity was 86.4% and specificity was 67.2% when considering 7-10 results as positive and 0-6 results as negative.
• 59.5% of the Investigate Further false positive results were still considered high risk lesions in that they were actively managed or treated by the study dermatologists.
• Overall diagnostic accuracy, i.e., Area Under the Curve (AUC), was 0.79, which was identical to the AUC in the FDA pivotal study with over 1,000 patients and 22 primary care study centers [8].

“These results further confirm that the DermaSensor device maintains consistent performance, in this case at a new health system and in the dermatology setting with patients’ suspicious lesions rather than primary care provider selected lesions,” said Dr. Laura K. Ferris, MD, PhD, who was the study’s Principal Investigator and is currently the Chair of Dermatology at UNC Chapel Hill. “This supports the device’s role as an important adjunctive tool for triage and clinical decision-making, helping non-dermatologists identify high-risk lesions with improved performance and confidence.”

The DERM-ASSESS III melanoma clinical utility study, published in JCAD, comprised of 118 PCPs that completed assessments of over 10,000 lesion cases. This study found that:

• Physician AUC improved significantly with the use of DermaSensor, from 0.630 to 0.671 (p = 0.036) [1].
• Melanoma detection increased from 70.2% to 79.1%, decreasing missed melanoma from 29.8% to 20.9% [1,5].
• 91.5% of the study physicians agreed the device added value to their clinical care [1].
• 75% agreed it would help detect more skin cancers [1,5].
• 71% reported increased confidence in evaluating skin lesions [1,8].

Clinical Significance

The DermaSensor solution offers rapid, objective assessment of skin lesions at the point of care, providing a 0-10 risk scale with “Investigate Further” or “Monitor” guidance within seconds for suspicious lesions [6,8]. Bridging gaps in dermatology access helps ensure timely evaluation of high-risk lesions while optimizing triage and resource allocation [1,3,5,8].

“By giving PCPs access to an AI-powered tool that objectively analyzes skin lesions in real time, we can help bridge the gap in dermatology access and ensure more patients receive timely, appropriate care,” said Dr. Falk, co-author and family medicine physician at Florida State University College of Medicine [1].

A Transformative Tool for the Future of Skin Cancer Detection

With rising skin cancer incidence nationwide, DermaSensor’s AI-powered, handheld device offers a scalable solution for improving detection, reducing unnecessary referrals, and enabling earlier intervention [2,5,8].

“This independent prospective UPMC study further reinforces that DermaSensor has strong and highly generalizable performance across different health systems and across the primary care and dermatology settings. Many published studies have shown that performance issues with generalizability and with skin of color are major shortcomings for image-based tools,” said Cody Simmons, CEO of DermaSensor. “Our spectroscopy-based system has already been used to test tens of thousands of lesions by several hundred doctors in the US, even though we just received FDA clearance last year. In the years to come, we look forward to our device helping tens of thousands of doctors to improve care for millions of patients.” [6,8]

About DermaSensor Inc.

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is currently FDA Cleared, CE Marked, and is available for sale in the U.S.

References

1. Seiverling, E.V. (2025). JCAD MRMC Study. Journal of Clinical and Aesthetic Dermatology, October 2025, 58–65. Link
2. American Cancer Society. Cancer Facts & Figures 2025.
3. Ferris, L.K., et al. (2025). DERM-SUCCESS FDA Pivotal Study. JCAD, 2025.
4. Manolakos, D., et al. (2024). AI-Enabled ESS in Primary Care. JAAD International, 2024.
5. DermaSensor Inc. (2025). FDA Clearance and AI-Powered Device Overview.
6. DermaSensor Inc. (2025). Published FDA Pivotal Studies – Sensitivity/PPV.
7. DermaSensor Inc. (2023). Device Performance Across Skin Tones.
8. Jaklitsch, E., Chang, S., Bruno, S., D’Angelo, N., Tung, J.K., Ferris, L.K. (2025). Prospective evaluation of an AI-enabled ESS device for triage of patient-identified skin lesions in dermatology clinics. JAAD International, Dec 2025. Mendeley Supplementary Data

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The financing follows strong early market traction, with the company already surpassing 20,000 skin lesions scanned with an average quarterly growth rate of 117% since its U.S. commercial launch in mid-2024, following FDA De Novo clearance in early 2024. This strong adoption underscores the demand in primary care for rapid assessments and clinically validated tools that empower physicians for early cancer detection. The device’s strong clinical performance and benefits have been recognized in several top-tier publications, such as Nature, and by many prestigious awards, including TIME’s Best Inventions of 2024.

DermaSensor’s optical spectroscopy technology from Boston University has been miniaturized from a large, microwave-sized device into a wireless, handheld device designed for a simple “point and click” user experience. By assessing features at a cellular level, rather than a lesion’s surface visual appearance, the device has been proven to have sensitivity between 96-100% in several published studies, with specificity as high as 77% for pigmented lesions. As the only automated skin cancer detection device of any kind available for primary care use in the US, the company expects its technology to remain the best-in-class solution. Just from the early commercial use of the device, the company’s AI training dataset has already increased several-fold since the 2,000 lesions originally used to train its currently cleared algorithm. In contrast, image-based AI solutions leverage publicly available datasets of millions of images, but none have been able to achieve FDA clearance despite several such solutions being available in other geographies, such as Europe, and some failing major studies to receive FDA clearance. Many recent publications have shown that applying AI to dermoscopy and/or clinical images presents many challenges, including poor performance on skin of color and also generalizability issues when used in different geographies or by various doctors.

“Having received FDA De Novo clearance of its FDA Breakthrough device last year, we are impressed with how quickly the company has been able to gain adoption for this new product category they have created,” said Dr. Preetha Ram, Managing Partner at Pier 70 Ventures. “We are proud to partner with DermaSensor to help empower primary care practices nationwide with an evidence-based and cost-effective solution that has been shown to improve clinical decisions and cancer detection.”

In addition to commercial expansion, the Series B funding will also support new pipeline programs as well as clinical evidence generation for the existing algorithm, which builds upon the pivotal study results showing that the device halves the rate of physicians’ missed skin cancers.

“With hundreds of physicians already using our device at health systems, and hundreds more at private practices, it is clear that our first-in-class device is having a major impact on patient care, with approximately 2,000 suspicious skin cancers already detected for referral to dermatology. While we are not yet announcing any details, we also have three active pipeline programs, all of which utilize the same device hardware that is currently in use by customers for running the current cleared algorithm,” said Cody Simmons, CEO and Co-Founder of DermaSensor. “Completing our financing in this challenging funding environment, especially at a modest increase in valuation from our early 2022 financing, is a result of our strong commercial traction, top-tier clinical evidence, and robust product pipeline for addressing this large, longstanding unmet clinical need.”

About DermaSensor Inc.

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ solution is a cost-effective handheld device that combines artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling immediate results at the point of care, DermaSensor is empowering physicians nationwide with a clinically proven solution for early skin cancer detection. DermaSensor is currently commercially available in the U.S.

To speak to a representative of DermaSensor please contact press@dermasensor.com

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MIAMI, Florida, June 12, 2025 / EINPresswire.com/ DermaSensor Inc., in collaboration with faculty from Mayo Clinic, Yale University, the University of North Carolina School of Medicine, and SUNY Downstate Health Sciences University, announced the publication of two pivotal studies validating the company’s novel Elastic Scattering Spectroscopy (ESS) device for skin cancer detection in primary care. One study assessed the standalone performance of the ESS device, while the second evaluated how device use impacted primary care physicians (PCPs) skin cancer detection and management.

In the multicenter validation study, led by Mayo Clinic, 1,005 patients and 1,579 lesions were evaluated across 22 primary care sites. Dermatopathologic analysis confirmed 224 skin cancers, including melanomas, basal cell carcinomas, and squamous cell carcinomas. The ESS device was found to have a skin cancer detection rate, or sensitivity, of 96%¹. This performance level compared favorably to the 90% target based on dermatologists’ sensitivity in the literature, which is also the FDA’s minimum required sensitivity for melanoma. For negative device results, the likelihood that a lesion was benign (i.e. negative predictive value (NPV)) was 97%. For positive results, the likelihood a lesion was cancerous (i.e. positive predictive value (PPV)) ranged from 6% for the lowest score of 1 to 61% for the highest score of 10.

“The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer assessment device with high sensitivity and NPV for use in the primary care setting. Use of the device can help inform PCP decision-making about skin lesions suspicious for cancer, which need further evaluation and those that may be monitored,” wrote Stephen Merry, MD, MPH, from Mayo Clinic in the abstract as lead author of the pivotal trial.

The companion clinical utility study with 108 physicians found that use of the ESS device significantly enhanced physicians’ ability to identify and correctly refer skin cancers and improved their overall skin lesion management accuracy. PCPs correctly referred 91.4% of malignant lesions when aided by the device, compared to just 82.0% without it—a 50% reduction in missed cancer referrals (from 18.0% to 8.6%)².

“I have spent most of my career researching and using skin cancer diagnostic tools. It has been a long-time unaddressed goal of the dermatology and primary care communities to have an easy-to-use tool that can provide an automated risk assessment for suspicious lesions.” said Laura Ferris, MD PhD, who is the Chair of Dermatology at UNC Chapel Hill, the lead author of this utility study, and a leading researcher on skin cancer diagnostic tools. “Now that DermaSensor is the first such tool available for PCPs and, given the clear device benefits that our study and others have demonstrated, I am optimistic for the impact this device will have on skin cancer detection and care.”

Skin cancer remains the most common cancer globally, accounting for more cases annually than all other cancers combined³. While many deadly skin cancer cases are preventable through sun protection and early detection, delayed diagnosis continues to drive unnecessary mortality, morbidity and high healthcare expenses.

“These two FDA pivotal studies – the main clinical studies of the six submitted to FDA – highlight the strong performance and benefits of our device, which were instrumental in DermaSensor becoming the first FDA-authorized tool in the US that provides anyone with any kind of objective risk assessment for melanoma, BCC and SCC.” said Cody Simmons, Co-Founder and CEO of DermaSensor. “Since receiving FDA De Novo clearance of this FDA Breakthrough Device last year, there are already hundreds of diverse doctors using our devices, and we are working to quickly scale device adoption so that our device can benefit many of the millions of patients that are diagnosed with skin cancer each year.”

About DermaSensor Inc.

DermaSensor Inc. is a Miami-based medical device company that enables healthcare professionals to effectively check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is a cost-effective handheld tool that uses artificial intelligence and spectroscopy to non-invasively test skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is currently FDA Cleared, CE Marked, and is available for sale in the U.S.

References

1. Merry SP, Croghan IT, Dukes KA, et al. Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer. Journal of Primary Care & Community Health. 2025;16. doi:10.1177/21501319251344423
2. Ferris LK, Jaklitsch E, Seiverling EV, et al. DERM-SUCCESS FDA Pivotal Study: A Multi-Reader Multi-Case Evaluation of Primary Care Physicians’ Skin Cancer Detection Using AI-Enabled Elastic Scattering Spectroscopy. Journal of Primary Care & Community Health. 2025;16. doi:10.1177/21501319251342106
3. https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/ accessed on June 6, 2025.

To speak to a representative of DermaSensor please contact press@dermasensor.com

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Carolyn Walsh Joins as Chief Commercial Officer

Carolyn Walsh brings over 25 years of commercial leadership experience spanning digital health, medical devices, and remote patient monitoring. Most recently, she served as Chief Commercial and Marketing Officer at BioIntelliSense, where she led the commercialization of the FDA-cleared BioButton® wearable medical devices and clinical intelligence solutions. Her prior roles include executive leadership positions at Fitbit Health Solutions, Qualcomm Life, and Johnson & Johnson. Throughout her career, she has consistently driven revenue growth, launched award-winning health technologies, and built high-performing commercial teams. At DermaSensor, she will lead commercial strategy and execution as the company scales its FDA Breakthrough, AI-powered skin cancer detection device across the U.S. market.

Commercial Advisory Board Members

DermaSensor is also pleased to announce the following industry leaders to its Commercial Advisory Board:

• Stephen F. Meyer – Former CEO of Welch Allyn and Operating Partner at Beecken Petty O’Keefe, Stephen is a veteran in medical device commercialization and a long-time advisor to health tech innovators.
• Andrew Livingston – former Co-founder and CEO of Doxy.me, the world’s largest telemedicine platform, and former Chief Innovation Officer at Harrow Health, Andrew brings deep experience in scaling digital health tools to private practices.
• Dr. Ainsley MacLean – Harvard-trained neuroradiologist and former CMIO/CAIO at Kaiser Permanente, Dr. MacLean is a leading expert in deploying novel AI solutions in healthcare systems.
• Jason Bellet – Co-founder and Chief Business Officer of Eko Health, Jason is a recognized AI-powered diagnostics leader, and his company has sold over 500,000 AI-powered stethoscopes worldwide.
• Mike Hennessy Jr. – President of MJH Life Sciences, one of the largest privately held healthcare marketing and data companies, Mike brings expertise in healthcare communications, oncology, and industry partnerships.

“With the addition of Carolyn and these esteemed advisors, we have greatly enhanced our ability to accelerate adoption of our device, a device which is the first and only AI-enabled medical device with a dermatology base intended use among the 1,000+ AI-enabled medical devices authorized by FDA¹,” said Cody Simmons, CEO and co-founder of DermaSensor. “With already having several leading health systems as customers and signing one new private practice a day, I am very excited to welcome these new industry leaders to further scale our commercial efforts and product adoption.” 

DermaSensor’s innovative device utilizes optical spectroscopy and AI to provide an objective, non invasive result for skin cancer risk. In published studies, the device has been shown to provide non-dermatologist providers with the diagnostic accuracy of in-person dermatologists in assessing a suspicious lesion, enabling them to cut their missed cancers by half, and could also decrease their unnecessary referrals.

About DermaSensor

DermaSensor Inc. is a Miami-based medical device company that seeks to enable healthcare professionals to efficiently check for skin cancer by leveraging cutting-edge technologies. The DermaSensor™ device is an affordable handheld tool that uses artificial intelligence and spectroscopy to evaluate skin lesions for skin cancer risk in seconds. By enabling quick and effective skin cancer checks, DermaSensor ultimately hopes to improve skin cancer detection and save lives. DermaSensor is currently FDA Cleared, CE Marked, and is available for sale in the U.S.

To speak to a representative of DermaSensor please contact press@dermasensor.com

Reference: 1. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices

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“We are ecstatic to receive these three prestigious awards all in the last month, which truly reflect the hard work and passion of our exceptional team over the last decade,” said Cody Simmons, Co-Founder and CEO of DermaSensor. “Being consistently recognized in recent years as being among the top innovators in technology and healthcare speaks volumes about our commitment to enhancing physician’s ability to detect skin cancer. We are dedicated to advancing our technology and expanding its adoption among the ~1 million physicians in the US to enable prompt skin cancer detection for all patients. Having just launched our device in the US this May, we are excited to make a big impact in skin care and public health in the years ahead.”

The DermaSensor device empowers physicians to non-invasively provide immediate, objective results for skin cancer risk to their patients. Prior to DermaSensor’s FDA clearance this year, there was no automated technology available in primary care for evaluating skin lesions suspicious for cancer. Skin cancer rates continue to rise but access to dermatology care is limited, with just 8% of Americans at risk for skin cancer receiving an annual skin exam[1]. This makes timely and accessible diagnosis crucial since when detected early, the 5-year survival rate for melanoma is 99 percent[2]. DermaSensor’s optical spectroscopy and AI technology enhances physicians’ diagnostic and referral capabilities, enabling prompt identification of skin cancer and effective prioritization of high-risk patients.

“At DermaSensor, we recognize a significant gap in the effective assessment of skin cancer risk, a critical concern for both patients and for clinicians who are not experts in dermatology. Our mission is to bridge this gap by delivering objective, reliable solutions that empower physicians to non-invasively test for skin cancer risk at the point of care.” describes Larry Anderson, Jr., CCO of DermaSensor, “our company’s dedication extends beyond merely providing a new technology; it encompasses promoting a proactive mindset towards skin health that serves the interests of all.”

About DermaSensor

DermaSensor Inc. is a health technology company designing non-invasive tools to better equip clinicians for skin cancer detection. The DermaSensor device is an affordable, handheld tool that uses spectroscopy and algorithms to immediately evaluate skin lesions for cancer. DermaSensor is currently FDA Cleared, CE Marked, and is available for sale in the U.S.

References: 1. https://www.aad.org/media/stats-skin-cancer 2. https://www.skincancer.org/skin-canskin lesions for cancer.

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Miami, Florida – October 30, 2024 (BUSINESS WIRE) – DermaSensor, a world leader in skin cancer diagnostic technology, announced today the company’s inclusion in TIME’s Best Inventions of 2024 list under the Medical Care category. TIME’s prestigious award recognizes 200 innovations that TIME editors deem as the most impactful new products and ideas globally.

The FDA Cleared, CE Marked DermaSensor device enables physicians to non-invasively provide immediate, objective results for skin cancer risk. Until DermaSensor’s clearance by FDA this year, there has been no device, test, or software available in primary care physician offices to evaluate suspicious skin lesions for cancer. With rising skin cancer rates, timely and accessible diagnosis is critical. DermaSensor enhances physicians’ diagnostic and referral capabilities, helping to address the common access challenges to dermatology services. Over one-third of patients experience delays or barriers to accessing dermatology care, making this device essential in promptly detecting and efficiently prioritizing high-risk referrals.

“We’re honored to be recognized for our role in advancing the fight against skin cancer. Our inclusion in TIME’s Best Inventions list reflects our team’s dedication and the urgent need for accessible skin cancer detection tools,” said Dr. Maurice Ferré, Co-Founder and Chairman of DermaSensor. “Our team created a solution that empowers physicians and patients alike, ensuring everyone has access to effective skin cancer evaluations.”

Designed for use across diverse healthcare settings, DermaSensor bridges the gap between primary care and dermatology, ensuring that more physicians can offer effective skin cancer evaluations. Its ease of use, portability, and non-invasive features make it an invaluable addition to routine exams, aiding in prompt detection and referral to dermatologists.

Cody Simmons, Co-Founder and CEO of DermaSensor Inc., added, “Everyone deserves access to high-quality care, and TIME’s recognition of DermaSensor aligns with our mission to make skin cancer detection available to all. Since our first device delivery in May, we have already equipped hundreds of physicians with this technology; it is a privilege to already be improving patient care with thousands of lesions scanned just in these first few months.”

About DermaSensor

DermaSensor Inc. is a health technology company designing non-invasive tools to better equip clinicians for skin cancer detection. The DermaSensor device is an affordable, handheld tool that uses spectroscopy and algorithms to immediately evaluate skin lesions for cancer. DermaSensor is currently FDA Cleared, CE Marked, and is available for sale in the U.S.

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