Miami, Florida, USA
2009
Healthcare, Medical Devices, Dermatology, Primary Care, Health Technology, Clinical Diagnostics
DermaSensor is a medical technology company developing an AI-powered skin cancer assessment device for use by healthcare professionals. Its handheld system combines elastic scattering spectroscopy (ESS) with machine learning to analyze suspicious skin lesions at the point of care. The technology evaluates optical characteristics beneath the skin’s surface and provides an objective result that helps clinicians determine whether a lesion should receive further evaluation. DermaSensor sits at the intersection of artificial intelligence, optical sensing, and medical diagnostics.
DermaSensor provides physicians with a non-invasive method for evaluating suspicious skin lesions during a clinical visit. A clinician places the handheld device against a lesion, where it collects spectral measurements and uses an AI algorithm to analyze characteristics associated with malignancy. The system returns an immediate result of either “Monitor” or “Investigate Further,” helping inform decisions about whether a patient should be referred to a dermatologist.
The device is designed to assist with lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma. It is an adjunct to clinical assessment rather than a standalone diagnostic or general screening tool.
DermaSensor combines elastic scattering spectroscopy (ESS) with a proprietary machine learning algorithm. ESS analyzes how light interacts with cellular and subcellular structures beneath the surface of a suspicious lesion. The device emits light into the tissue and measures reflected spectral signals associated with characteristics such as cell density, nucleus size, chromatin, tissue architecture, and melanocyte density.
During an assessment, the device collects multiple spectral recordings from different areas of the lesion. DermaSensor says each recording measures reflectance across 47 wavelengths, creating spectral information that can be evaluated for patterns associated with benign or malignant tissue.
These measurements are processed by a locked, validated AI algorithm trained using more than 20,000 scans from over 4,000 malignant and benign lesions. The analysis produces an immediate “Monitor” or “Investigate Further” result. For an Investigate Further result, the system also provides a spectral score indicating the degree of similarity to malignant lesions.
DermaSensor demonstrates how AI can be combined with optical sensing to provide clinicians with information that cannot be obtained from visual examination alone. Rather than relying on conventional medical images, its technology analyzes spectral characteristics associated with microscopic tissue structures beneath the skin.
The system is particularly relevant to the growing use of AI-assisted point-of-care diagnostics. Its FDA-cleared device gives non-dermatologist physicians an objective tool for evaluating suspicious lesions and deciding when further dermatological assessment may be appropriate. In its pivotal study, the device demonstrated 96% sensitivity across melanoma, basal cell carcinoma, and squamous cell carcinoma.
The DermaSensor device is a handheld AI-powered skin lesion assessment system designed for clinical point-of-care use. Physicians place the device directly against a suspicious lesion to collect non-invasive spectral measurements. The measurements are analyzed by the device’s ESS and machine learning technology, producing an immediate result intended to support clinical decision-making.
The device can evaluate lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma. It also supports secure Wi-Fi connectivity, cloud-based data synchronization, remote device monitoring, and delivery of software updates.
DermaSensor is primarily used for skin cancer risk assessment in clinical settings. It is designed for physicians who are not dermatologists and can be incorporated into primary-care visits when a suspicious skin lesion has already been identified.
Its applications include evaluating lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma, supporting decisions about dermatology referrals, and helping healthcare systems prioritize patients requiring additional evaluation. DermaSensor can therefore serve as a bridge between primary care and specialist dermatology services. The device is indicated for patients aged 40 and older and is not intended as a general skin-cancer screening device or as the sole basis for diagnosis.
DermaSensor uses elastic scattering spectroscopy to send light into tissue and measure how that light is reflected by cellular and subcellular structures. Its AI algorithm analyzes the resulting spectral information for patterns associated with malignancy.
The device is indicated to assist in evaluating lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma—the three common forms of skin cancer addressed by the system.
Yes. DermaSensor received FDA clearance in 2024 as a Class II medical device for assisting physicians in evaluating lesions suggestive of melanoma, basal cell carcinoma, and squamous cell carcinoma.
No. DermaSensor is not intended to provide a definitive skin-cancer diagnosis. It provides objective information that physicians can use alongside their clinical assessment when deciding whether a suspicious lesion requires further evaluation or referral to a dermatologist.
DermaSensor is designed for physicians who are not dermatologists and other qualified healthcare professionals using it in clinical settings. It is not intended for patients to perform their own skin assessments.
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