Articles from DermaSensor Inc.

DermaSensor, a health technology company transforming skin cancer detection with AI-powered technology, today announced it has received Class IIb CE Mark for the DermaSensor device, enabling commercialization across the European Economic Area (EEA) and marking the beginning of the company’s global expansion strategy.

DermaSensor Inc., a health technology company designing non-invasive tools to better equip primary care physicians for skin cancer detection, today announced the publication of research demonstrating that its device can help clinicians more accurately detect skin cancer, while also effectively ruling out the majority of referrals of benign lesions that patients were concerned were cancerous.

DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for evaluating suspicious skin lesions and a proud member of the AAFP Foundation Partnership Program, is proud to recognize The FSU Family Medicine Residency Program - BayCare Health System (Winter Haven) in becoming the country’s first Family Medicine Physician Residency Program to integrate DermaSensor into its curriculum. This innovative initiative underscores the program's commitment to providing comprehensive healthcare and enhancing the skills of future family medicine physicians.

DermaSensor Inc., a health technology company equipping physicians with a non-invasive device for use in the evaluation of suspicious skin lesions, announces the publication of strong results from a multi-center, prospective device validation study for melanoma detection. The study, titled “DERMaSensor Use in the ASSESSment of Skin Lesions Suggestive of Melanoma III (DERM-ASSESS III)”, was conducted across 8 United States and 2 Australian sites and was published in JAAD (Journal of the American Academy of Dermatology) International.1

DermaSensor Inc. announces FDA clearance for its real-time, non-invasive skin cancer evaluation system. For the first time, the 300,000 primary care physicians in the U.S. can now be equipped to provide quantitative, point-of-care testing for all types of skin cancer. Better identifying skin cancer in a primary care setting is designed to accelerate patient access to necessary care.

DermaSensor Inc., the pioneer of the first point-and-click skin cancer detection device for primary care physicians, announces the publication of a new study1 in the Journal of Primary Care and Community Health. This study, authored by medical leaders including Laura Korb Ferris, MD, and Todd Thames, MD, evaluated the impact of the DermaSensor device on PCPs’ skin cancer diagnosis and management. The study involved 57 U.S. board-certified PCPs who collectively completed over 5,000 assessments of skin lesions.1

DermaSensor Inc. – Skin cancer is a global health concern, with increasing incidence rates worldwide. Artificial Intelligence (AI) is expanding its presence within dermatology with several tools available abroad, although no skin cancer AI imaging tools are currently available in the U.S. that are approved by the FDA. A newly published study was designed to evaluate the safety and effectiveness of an Elastic Scattering Spectroscopy (ESS) device, the DermaSensor device, in assessing skin lesions suggestive of skin cancer. This study was conducted to provide clinical evidence for European regulatory authorities and initial effectiveness evidence for the FDA. The device has been under review by the FDA since early 2023; it is not currently available for sale in the United States.

DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for evaluating suspicious skin lesions, presented today promising results from a sub-analysis of the DERM-SUCCESS study.1 The analysis focused on the performance of DermaSensor’s handheld Elastic Scattering Spectroscopy (ESS) device in detecting skin cancer in patients across different Fitzpatrick skin types, a skin tone scale developed to classify skin coloring and response to ultraviolet (UV) radiation.2 In the study, DermaSensor’s ESS device demonstrated high sensitivity of 96% in detecting all skin cancer types when compared to the gold standard of histopathologic examination, with similar sensitivity and specificity across Fitzpatrick skin type subgroups.

DermaSensor Inc., in collaboration with leading medical institutions such as Mayo Clinic and the University of Connecticut School of Medicine, marked the commencement of Skin Cancer Awareness Month by presenting the successful validation and utility of the company’s novel Elastic Scattering Spectroscopy (ESS) device in assisting primary care physician's (PCPs) detection of skin cancers. Of the two studies presented, one demonstrated the standalone performance of the hand-held, non-invasive device, and the other evaluated the impact of the device on PCPs’ management of skin cancer.

DermaSensor Inc., a health technology company equipping primary care physicians (PCPs) with a non-invasive device for use in evaluation of suspicious skin lesions, presented a pooled analysis today from two clinical studies evaluating the performance of the company's device in detecting skin cancer. In the DERM-ASSESS III and DERM-SUCCESS clinical studies, the device had a sensitivity of 94% for correctly classifying the 338 high risk lesions and a specificity of 23% for correctly classifying 1,681 low risk lesions, all of which were biopsied by physicians for suspicion of skin cancer. Underscoring the effectiveness of DermaSensor’s non-invasive, optical spectroscopy technology, the device met its primary endpoint in the pivotal study (DERM-SUCCESS) of having higher sensitivity than PCPs for all common skin cancers.