The integration of Artificial Intelligence (AI) into healthcare is fundamentally transforming medical care, in large part by improving the diagnostic capabilities of frontline providers. A prime example of this paradigm shift is DermaSensor, an innovative, handheld, AI-powered device designed for early skin cancer detection. Receiving FDA clearance in January 2024, DermaSensor leverages elastic scattering spectroscopy (ESS) to meticulously analyze tissue at a cellular level, enabling it to accurately differentiate between benign and malignant skin lesions.
The development of DermaSensor involved algorithm training with over 10,000 diagnosed spectral readings, and the clinical effectiveness testing was conducted through six different prospective clinical studies that were submitted to the FDA, all of which successfully demonstrated the device’s robust performance. Already hundreds of diverse physicians are using the device to test suspicious skin lesions for skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma. The device is helping to “democratize” effective skin cancer exams, as it empowers primary care physicians to assess a given suspicious lesion as accurately as a dermatologist, according to two studies published in a journal of the American Academy of Dermatology (AAD). Patients having access to non-invasive skin cancer detection in the primary care setting is crucial for early detection and intervention, since 5-year survival rates are 99% when melanoma is detected early yet only 8% of Americans at risk for skin cancer receive an annual skin exam. A key advantage of DermaSensor is its consistent performance across all skin tones, since technical publications and published studies show no meaningful performance difference based on skin type. The device’s user-friendly interface simplifies the process for clinicians, providing an immediate and clear 0-10 risk score to guide their management decision (e.g. refer, monitor).
Clinical trials have underscored DermaSensor’s impressive performance, demonstrating a 95.5% sensitivity across the three common skin cancer types. Accordingly, for a negative result of “Monitor” the device’s negative predictive value (NPV) has been shown to be 97-99%, depending on the study. For lesions with a positive result of “Investigate Further”, the accompanying 1-10 risk score was found to have a malignancy likelihood of 6% for a score of 1 and 61% for 10 in the FDA pivotal study DERM-SUCCESS, which enrolled over 1,000 patients across 22 study centers. This risk result provides helpful insight to the clinician on the level of suspicion of that given lesion. Not only is this the first device that enables any physician to receive an immediate, objective result for skin cancer risk, but the device’s accuracy was consistently found to surpass that of primary care physicians and was found to be at least as high as that of dermatologists. While powerful, the FDA advises that DermaSensor be used in conjunction with a comprehensive clinical assessment for suspicious lesions, clarifying that it is not intended as a standalone screening tool for all lesions.
The AI healthcare market is experiencing rapid expansion, with varied established industry titans and also small tech startups at the forefront of this technological revolution. The FDA provided a list of all AI-enabled FDA authorized medical devices at the end of 2024, and the list totaled just over 1,000 devices. The only device listed that was indicated for any dermatology application was DermaSensor. While DermaSensor stands out due to its specific focus on skin cancer and also empowering primary care, it is part of a broader trend of portable, AI-assisted medical devices transforming healthcare delivery. Notable examples include Butterfly Network’s portable ultrasound, which brings advanced imaging capabilities to diverse settings, and Eko Health’s AI-powered stethoscope, enhancing cardiac and pulmonary assessments. Jason Bellet, co-founder of Eko Health and an advisor to DermaSensor, also foresees a rapid and substantial growth in the adoption of handheld AI-assisted medical devices within primary care. For example, Eko Health recently announced that it has sold over 500,000 of its AI-powered stethoscopes. By demonstrating proven effectiveness, user-friendliness, and seamless integration into existing clinical workflows, such tools pave the way for a more accessible and efficient healthcare system.
