“Our ambition is to establish objective skin cancer risk assessments as the ‘new normal’ for frontline skin care.” — Cody Simmons, Co-Founder, CEO, and Director of DermaSensor, Inc.

Physicians confront a critical decision that arises when a patient presents with an unusual skin lesion: is this something that can wait, or does it demand dermatologist’s attention? Visual inspection alone leaves too much room for doubt, especially for physicians not specialized in dermatology, and delayed detection of skin cancer can cost lives. A practical, objective tool is now changing that equation in clinics nationwide.

DermaSensor, Inc. has developed the only FDA-cleared, automated device that uses artificial intelligence to non-invasively assess risk for all three common skin cancers. Built for everyday primary care workflows, the handheld technology delivers rapid, data-driven results that strengthen clinical confidence at the moment of examination. The FDA pivotal study data shows 81 percent of physicians report greater certainty when evaluating lesions, a 52 percent drop in missed cancer referrals, and 96 percent sensitivity across the most common skin cancers. More than 47,000 suspicious lesions have already been scanned, and the device is trusted across hundreds of practices, from family medicine and health systems to specialty and value-based care settings.

Clinicians call it a rare win for patients, providers, dermatologists, and insurers alike. Patients gain clearer answers, primary care teams make more timely referrals, specialists receive higher-priority cases, and payers see earlier intervention when malignancy is present. DermaSensor’s mission is direct: equip healthcare professionals with breakthrough, data-driven solutions that improve early detection and save lives. Anchored in the company values of integrity, collaborative accountability, innovative excellence, and a people-first commitment, the company continues to raise the standard of care by putting both clinicians and the communities they serve at the center of every advance.

At CIO Bulletin, we had the distinct honor of interviewing Cody Simmons, CEO and Director of DermaSensor, Inc. He shared profound insights on how his company brings objective, data-driven insight into the examination room, helping clinicians make more informed decisions about potential skin cancer, guide appropriate referrals, strengthen patient care, and ultimately save lives.

Interview Highlights

What inspired the founding vision behind the company, and how did your journey evolve to overcome early engineering and clinical hurdles in pioneering point-of-care optical spectroscopy?

DermaSensor was founded with a clear mission: to empower healthcare providers with data-driven, breakthrough solutions that improve early skin cancer detection and save lives.

Our founders recognized a fundamental gap in healthcare. Skin cancer is highly treatable when detected early, yet access to dermatology is limited and frontline physicians historically have had no objective tools to help evaluate suspicious lesions. In 2009, DermaSensor’s founders connected with Dr. Irving Bigio of Boston University, the original inventor of Elastic Scattering Spectroscopy (ESS), and saw the potential to use this powerful optical technology to solve this problem

The engineering challenge was significant. Early ESS systems were large laboratory instruments. Over years of development, our team miniaturized the technology into a handheld device while simultaneously building the clinical evidence and machine-learning capabilities required for real-world use.

That journey ultimately led to FDA De Novo clearance in 2024, creating an entirely new category of AI-powered skin cancer detection technology for primary care physicians.

Can you brief us about your products and services? What key innovations make them stand apart in the current market?

DermaSensor is a handheld, non-invasive device that uses AI-powered Elastic Scattering Spectroscopy to assess suspicious skin lesions for melanoma, basal cell carcinoma and squamous cell carcinoma.

Unlike image-based technologies that analyze a photograph of a lesion’s surface, DermaSensor uses light to evaluate cellular and subcellular characteristics beneath the skin’s surface. The device analyzes spectral information and provides physicians with an objective skin cancer risk result during the patient exam.

That combination of spectroscopy, machine learning and a highly portable point-of-care device is what differentiates DermaSensor. We are the first and only automated device authorized by the FDA for detection of all three common skin cancers and the first and only for use by physicians who are not specialists.

Just as importantly, the technology was designed to fit naturally into the clinical workflow rather than create another complicated diagnostic process.

With your DermaSensor device being the first FDA-cleared AI solution for skin cancer, how does your Elastic Scattering Spectroscopy technology empower primary care physicians to dramatically reduce missed malignancies?

Primary care physicians are often the first clinicians to see a suspicious lesion, but most do not have specialized dermatology training or objective technology available in the exam room.

DermaSensor helps address that gap by providing additional data at the point of care. The device emits light across multiple wavelengths and analyzes how that light interacts with the tissue. Its machine-learning algorithm evaluates the spectral characteristics associated with malignancy and provides a result designed to assist the physician’s referral decision.

Published clinical studies have demonstrated that incorporating DermaSensor results can improve physicians’ ability to appropriately refer suspicious skin cancers. In our FDA pivotal study with over 100 physicians, device use decreased physicians’ missed skin cancers by 52%. This is particularly important because earlier referral can mean earlier diagnosis and treatment.

Our goal is not to replace physician judgment or dermatologists. It is to give frontline clinicians better information when they are making an important decision about whether a suspicious lesion warrants further investigation.

What distinctive leadership philosophy and organizational culture have enabled your team to navigate strict regulatory landscapes while continually outpacing market expectations?

Medical technology requires patience, rigor, and a willingness to solve extremely difficult problems. Our culture combines those qualities with an entrepreneurial mindset focused on execution.

DermaSensor has brought together leaders with experience across medical devices, biotechnology, healthcare commercialization and technology. Our team has helped build and scale products at organizations including Genentech, Abbott, ResMed, and Qualcomm, while our founders and board bring experience building and successfully exiting major medical-device companies.

That experience has created a culture where clinical evidence, regulatory discipline and commercial execution are not separate priorities; they work together.

We also remain intensely focused on the clinician and patient experience. Innovation only matters if physicians can realistically incorporate it into their workflow and it ultimately helps improve patient care.

In an era where data security and algorithm locking are paramount, how do you build clinician trust around objective AI outputs without disrupting established medical workflows?

Trust in medical AI begins with clinical validation, regulatory rigor, and transparency around how the technology should be used.

DermaSensor is not intended to replace a physician’s clinical assessment. It provides an objective result that physicians use alongside clinically relevant information, including their visual assessment of the lesion.

We deliberately designed the experience to be simple. The physician identifies a suspicious lesion, uses the handheld device during the visit and receives an objective result that can help inform the referral decision.

We are also building a unique proprietary spectral dataset through real-world device utilization. With tens of thousands of lesions already scanned and a clinical registry supporting deidentified data collection, that dataset creates opportunities to further advance our technology while maintaining the rigorous clinical and regulatory standards expected of a medical device.

How does your non-invasive, objective risk-scoring model deliver a “quadruple win”—enhancing patient peace-of-mind, provider confidence, dermatologist triage, and healthcare payer efficiency?

The opportunity is to improve decision-making throughout the skin cancer care pathway.

For patients, an objective assessment during the initial visit can provide critical information and reinforce the importance of following through when a dermatology referral is recommended.

For frontline physicians, DermaSensor provides objective data to improve and complement their clinical assessment. In our FDA pivotal clinical utility study involving more than 100 physicians, 81% reported increased confidence when using the device.

For dermatologists, better-informed referral decisions from PCPs have the potential to help prioritize patients who require specialist evaluation.

And at a broader health-system level, improving referral decisions and detecting cancers earlier has the potential to support more efficient use of healthcare resources. Our objective is to help get the right patients to dermatology at the right time.

Being recognized among the “Leading Companies to Watch” is a significant achievement. What key operational milestones and technological breakthroughs positioned your organization at the forefront of medical AI innovation?

The past several years have been transformational for DermaSensor.

We received FDA De Novo clearance in 2024 and subsequently launched commercially in the United States. Since then, hundreds of practices and ten U.S. health systems have adopted the technology, more than 40,000 lesions have been scanned, and nine clinical studies have been published to date.

Commercially, contracted devices and annual recurring revenue tripled from year-end 2024 to 2025, a growth metric that we are on track to replicate again this year.

We have also received significant external recognition, including being named one of TIME’s Best Inventions of 2024 and an Inc. Best in Innovation honoree.

Most recently, receiving our Class IIb CE Mark created an important pathway for European commercialization and represents the beginning of DermaSensor’s next stage of global expansion.

Looking ahead into 2026, what expansion strategies, hardware iterations, or international regulatory expansions are on your immediate roadmap to scale global access to early skin cancer detection?

2026 is focused on scaling both our U.S. commercial footprint and our international presence.

In the United States, we are expanding adoption across independent practices, health systems, and strategic distribution channels. For example, we just announced four new major U.S. commercial partnerships, including being an approved supplier of Henry Schein. We are also continuing to generate clinical evidence and develop next-generation algorithms that we expect can be delivered through our existing device platform.

Internationally, our Class IIb CE Mark enables commercialization across Europe. We are actively developing commercial partnerships and working with healthcare systems and physician leaders to support adoption.

We also have a collaboration underway with England’s National Health Service, which represents an important opportunity to evaluate the technology within one of the world’s largest healthcare systems.

The broader goal is straightforward: to make objective skin cancer detection increasingly accessible wherever patients first present with suspicious lesions.

As generative and predictive AI reshape diagnostic medicine, how is your company positioned to lead this paradigm shift and adapt to evolving healthcare standards over the next decade?

We believe the future of medical AI will be defined not simply by larger algorithms, but by access to differentiated, clinically meaningful data.

DermaSensor has an important advantage because our AI is built around proprietary spectral data generated by our device rather than publicly available images. Every scan creates a type of information that cannot be captured by a smartphone camera or conventional imaging system.

As adoption grows, so does the potential depth of that dataset. Our customers are already performing thousands of scans each month, and our clinical registry provides a framework for deidentified data to support future research and algorithm development.

Over the next decade, we see an opportunity to continually improve what clinicians can learn from a simple, non-invasive optical scan. Our ambition is to establish objective skin cancer risk assessments as the “new normal” for frontline skin care.

Cody Simmons | Co-Founder, CEO, and Director 

Cody Simmons is a bioengineer and entrepreneur who has dedicated his career to bringing advanced healthcare technologies to physicians and patients.

He earned degrees in Economics & Entrepreneurship and Bioengineering from Brown University and completed graduate research at Stanford University. Before DermaSensor, Cody worked in business development and commercial strategy at Genentech and led business development for a Silicon Valley medical-device screening company.

Cody was selected by DermaSensor’s founders to transform the company’s early research and technology into a commercially viable medical device. Under his leadership, DermaSensor progressed from development through extensive clinical validation, FDA clearance, U.S. commercialization and European CE Mark certification.

He was also recognized in Forbes’ 30 Under 30 Healthcare category in 2017.

“Our broader goal is straightforward: to make objective skin cancer detection increasingly accessible wherever patients first present with suspicious lesions.”