How can we help you?

DermaSensor uses Elastic Scattering Spectroscopy (ESS) to analyze backscattered light from cellular and sub-cellular features of a suspicious lesion. A locked, validated AI algorithm processes the data and delivers an immediate result of either “Investigate Further” or “Monitor”. The device is not intended for direct diagnosis and should be used alongside clinical assessment.

DermaSensor is intended for physicians who are not specialists. It is designed for use in clinical settings to support evaluation and management decisions. The device is not intended for patient self-use.

DermaSensor analyzes spectral patterns to detect cellular features associated with melanoma, basil cell carcinoma, and squamous cell carcinoma, providing an immediate point-of-care result of either “Investigate Further” or “Monitor”. It is designed as an adjunctive tool used alongside clinical assessment, not as a replacement for clinical judgment. In FDA-submitted studies, PCP’s sensitivity to correctly evaluate lesions increased from 80.5-82.0% without device use to 86.3-91.4% with device use.

DermaSensor provides one of two outputs:“Investigate Further” or “Monitor.”, For lesions classified as “Investigate Further,” a 1-10 score reflects the degree of similarity to malignant lesions observed in validation studies. In the DERM-SUCCESS FDA Pivotal Study, the Negative Predictive Value (NPV) for a Monitor result was 97%. The Positive Predictive Value (PPV) for the 1-10 Investigate Further results ranged from 6% for a result of 1 to 61% for a result of 10.

A skin cancer detection device is a medical tool used by clinicians to help evaluate skin lesions that may be cancerous. The DermaSensor™ device is an FDA Cleared skin cancer detection device designed to assist physicians in evaluating suspicious lesions.

Yes. DermaSensor was cleared by the FDA in 2024 following a one-year interactive review process of six clinical studies and two non-clinical studies submitted by the company. The regulatory pathway that FDA has designated for Skin Lesion Analyzers (SLAs) like DermaSensor is as Class II medical devices. DermaSensor is indicated to assist physicians in evaluating lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma.

No. The DermaSensor device is not intended to be used for direct diagnosis of skin cancer. It provides objective data to assist physicians in deciding whether a lesion requires further clinical care, such as referral to a dermatologist.

In a prospective, multi-center primary care study, the device demonstrated an overall 96% sensitivity for evaluating skin cancer risk. DermaSensor provides objective results supported by validated clinical studies.

Yes. The DermaSensor device is indicated to assist in evaluating lesions suggestive of melanoma, and in the dermatology validation study the device demonstrated 96% sensitivity for melanoma detection.

Yes. The device takes non-invasive spectral recordings of a lesion without removing tissue. DermaSensor uses Elastic Scattering Spectroscopy (ESS) technology to evaluate cellular-level features for cancer automatically at the point of care.

DermaSensor is only for use by physicians for lesions deemed as suspicious for skin cancer. It is not intended for consumer or at-home use.

DermaSensor should be used in conjunction with the totality of clinically relevant information from the clinical assessment, including visual analysis of the lesion, by physicians who are not dermatologists. The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool. The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer. It is not intended for consumer or at-home use. The primary risks of DermaSensor are that false negative results (e.g., when a test indicates that a condition is absent when it is actually present) could lead to failure to treat cancer and cancer progression, or false positive results (when a test indicates that a condition is present when it is actually absent) could lead to unnecessary referrals and/or medical procedures. For a complete list of risks, please see the DermaSensor instructions for use.

DermaSensor is indicated for use by physicians who evaluate suspicious skin lesions, including family medicine physicians, internal medicine physicians, and community health physicians. It is designed for point-of-care clinical use across a range of medical settings.

The device is specifically designed to assist these clinicians in making informed referral
decisions to dermatology, providing an objective, point-of-care assessment tool to complement their clinical judgment. While the DermaSensor FDA pivotal validation study included 1,579 lesions biopsied by primary care physicians, and a supplemental melanoma validation study was conducted with biopsied lesions in the dermatology setting, note that the device indication for use is non-dermatologist physicians since the FDA’s clearance was based on the benefit-risk evaluation for physicians who are not experts in the clinical diagnosis and management of skin cancer.

DermaSensor is used in family medicine, internal medicine, concierge practices,health systems, community health and worksite clinics. It is designed for point-of-care use during routine patient visits where a clinician is evaluating a suspicious skin lesion.

DermaSensor uses Elastic Scattering Spectroscopy (ESS) to assess tissue at a cellular level beneath the skin surface and provide an objective risk result. This gives clinicians additional information to support their evaluation of suspicious lesions and clinical decision-making.

Yes. Consumer skin cancer apps use smartphone cameras to capture images of lesions. DermaSensor uses ESS technology to assess tissue beneath the skin surface and is FDA Cleared for clinical use – a fundamentally different standard from consumer image-based tools. Apps in app stores have been fined and shut down in the past for making unvalidated claims to consumers. DermaSensor is the only FDA cleared device or tool of any kind that provides any form of risk assessment for all three common skin cancers. No FDA cleared tools are available for at-home use or patient use.

Yes. DermaSensor is designed to support consistent, point-of-care lesion assessment across multi-site clinical environments. It helps reduce diagnostic variability between providers and locations.

You can locate clinics using DermaSensor through the DermaSensor Physician Finder. Search by ZIP code, city, or state to find a participating provider near you.

We have purposely designed our device to be both affordable and accessible to the greatest number of physicians by making it available on a monthly rental basis, so you avoid the expense of an upfront capital cost while being able to choose from different monthly rental packages based on your anticipated use of the proprietary device and FDA-cleared algorithm. Furthermore, our monthly rental gives you access to a world of additional benefits, such as software updates, customer support, replacement devices in the event of device failure, cloud storage for device results, remote device monitoring by DermaSensor, access to webinars and publications, and more.

We don’t have a published price for an outright purchase, but we can explore options. Please click here to request a demo for our pricing offers, email sales at sales@dermasensor.com or call us at +1-855-373-6767

DermaSensor services may be provided on the same date-of-service as an E/M visit or Annual Wellness Visit (G0439). The physician may consider it appropriate to report use of DermaSensor under an unlisted (96999 or 17999) CPT code. Many government and commercial plans provide coverage for DermaSensor services; however, services may be considered experimental / investigational and therefore non-covered by some payers. Patients may choose to receive a non-covered service and pay separately for that service out-of-pocket. Physicians should follow payer guidance to appropriately document a patient’s decision to pay separately for such services. To learn more, please contact the DermaSensor Reimbursement Hotline at 1-888-298-8848 (Monday-Friday from 8:00am – 8:00pm ET) or via email at reimbusement@dermasensor.com.

DermaSensor offers a one-year subscription plan for its customers, so your device use agreement allows you to try and use the DermaSensor device with reason after one year of use. So, the only financial commitment you make when you sign up as a customer is just twelve months of use.

Yes, we offer customer support by email, phone and on-demand resources.
Customer Support services Monday-Friday 8:00am EDT – 6:00pm EDT

Email: support@dermasensor.com
Phone: 855.373.6767

Unlisted CPT code options to consider for DermaSensor services include 96999 and 17999.¹ Reimbursement varies by payer and region. It is the responsibility of the rendering provider to determine and report appropriate codes, modifiers, and charges for health care services rendered to patients in their care.

We have ongoing clinical trials and also a process to support trials that you may be interested in pursuing. If you’d like to discuss any of these further, then please contact medical affairs at medaffairs@dermasensor.com

No certification is required to use DermaSensor. Instruction and education on proper usage and handling are fully covered in the Instructions For Use that is included in the device packaging and can be provided by our commercial team. Supplemental educational materials (e.g. Quick Reference Guide, videos, and patient education materials) are also available to all customers.

No. We locked the algorithm, per FDA requirements, and validated the performance through multiple prospective clinical studies. We plan to revalidate and periodically update the algorithm every few years, as we have to resubmit to the FDA and get clearance every time the algorithm is updated or new algorithms are added.

No, the device does not provide an output that differentiates between a BCC, SCC, or melanoma when signs of malignancy are present. It will provide the objective output of “Investigate Further” with a scale of 1-10 to indicate the degree of similarity to malignant lesions. The likelihood that a positive “Investigate Further” result is cancerous ranged from 6% for a score of 1 to 61% for a score of 10 in the DERM-SUCCESS FDA Pivotal Clinical Study with over 1,000 patients and over 200 skin cancers.

Not presently, but we will certainly be integrating with EHRs over time, depending on device usage and integration needs of our customers. . Most commonly, an electronic version of the DermaSensor report is uploaded to the patient’s record in the EHR. Alternatively, , clinicians document the device use and result by simply typing in two things to the EHR for the given patient; the 0-10 device result and the unique device number provided for each lesion. Other options that customers have been implementing include the use of dotphrases, smartphrases, and/or taking a photo of the device result screen with EHR photo apps.

DermaSensor demonstrated 96% sensitivity for detecting all common skin cancers in its DERM-SUCCESS pivotal clinical trial The device was also found to have a 96% sensitivity for melanoma in the supplemental DERM-ASSESS III dermatology validation study. These studies also found that the overall device accuracy (i.e. Area Under the Curve) was higher than PCPs (DERM-SUCCESS) and as high as dermatologists (DERM-ASSESS III) This high skin cancer detection accuracy helps ensure that malignant lesions are correctly managed for further clinical investigation.

DermaSensor’s performance is supported by multiple prospective, multi-center studies, including the DERM-SUCCESS pivotal trial across 22 study centers with over 1,000 patients and over 200 skin cancers. This study demonstrated 96% sensitivity for detecting all common skin cancers, validated against gold-standard dermatopathology.

The device was found to have a 96% sensitivity and 98% negative predictive value (NPV) for melanoma in the DERM-ASSESS III dermatology melanoma validation study with 10 dermatology study centers, providing high confidence when a “Monitor” result is issued. In this dermatology study, the likelihood of melanoma was 10% for 1-3 results, 21% for 4-7 results, and 47% for 8-10 results DermaSensor is the first FDA-cleared automated device indicated for melanoma, BCC, and SCC.

In clinical studies, the device sensitivity has consistently been superior to PCPs and on par with both dermatologists and dermatopathologists in their diagnosis of each of the three skin cancers. When PCPs used the device, their relative decrease in missed skin cancers (false negative referrals) was between 30% and 52%. This significantly improves the safety and reliability of the primary care skin check. This could also help protect clinicians from medical malpractice claims, not only by improving cancer detection but also demonstrating that the clinician went above and beyond the standard of care by using a FDA cleared device demonstrated to significantly reduce missed skin cancers.

Yes, the device is the first FDA-cleared automated tool indicated for Melanoma, Basal Cell Carcinoma, and Squamous Cell Carcinoma. In various studies, it has shown reliable sensitivity of at least 90% across all three categories.

The DermaSensor device result is determined using a proprietary AIalgorithm that has been developed and validated through clinical studies on thousands of diagnosed lesions. It was trained on a database of over 20,000 scans to ensure robust performance.

No, the DermaSensor device is intended to assist the user in deciding whether skin lesions require further clinical care and is not intended to be used for the direct diagnosis of skin cancer. The standard of care for a definitive diagnosis of a skin lesion is a biopsy followed by histopathology diagnosis.

Yes, in a prospective study, the device maintained sensitivity comparable to dermatologists, showing 96% device sensitivity vs 91% dermatologists’ sensitivity. The overall accuracy (Area Under the Curve) of the device was 76%, which was also comparable to the dermatologists’ accuracy of 75%. This makes it an ideal tool for non-specialist clinicians looking for accurate, objective diagnostic support.

DermaSensor has been evaluated in many published studies in both primary care and dermatology settings, some were early effectiveness studies and some were validation studies. The device sensitivity has always been found to be at least 90% across all three skin cancers, and device specificity has ranged from 21% (physician-biopsied lesions) to 61% (patient-selected lesions).