DermaSensor Granted FDA Breakthrough Device Designation
May 11, 2021, Miami, Florida — DermaSensor Inc., a health technology company designing non-invasive tools to better equip primary care providers for skin cancer checks, has been awarded breakthrough device designation by the FDA. The designation ensures close collaboration with and expedited review by the FDA, and provides formal acknowledgement that the DermaSensor device is addressing life-threatening disease and is expected to offer improved effectiveness compared to currently available products. Indeed, the company expects its product to be the first ever FDA cleared or approved skin cancer detection device for primary care providers.
The DermaSensor device was designed as an objective tool to support the assessment of lesions suggestive of skin cancer. Skin cancer is the most common form of cancer in the US and melanoma is expected to be the second most common cancer in the US by 2040. After frontline providers identify a lesion of concern for skin cancer on their patient, they gently touch the small, non-invasive device tip to the lesion. The tool takes instant spectroscopic recordings, emitting light and capturing the wavelengths of light that scatter off cellular structures beneath the skin’s surface and then back to the spectral sensor. It then uses a proprietary machine learning algorithm that analyzes the light and provides an immediate, objective result.
“DermaSensor’s ability to analyze and provide feedback on cellular substructure, which is invisible to the human eye even when aided by a dermatoscope, and to accomplish this in seconds, will empower healthcare providers at the important moment of patient assessment and medical decision making.,” remarked Global Senior Medical Director, Dr. Jeanett Segal, “Putting an early skin cancer detection tool in the hands of primary care providers means that we are better connecting the clinical front line with specialists and giving them greater information and a measurable means of assessing likelihood of a skin cancer.”
DermaSensor is poised to greatly improve access to effective skin cancer detection and care with its simple point-and-click, non-invasive tool, as there are hundreds of thousands of primary care providers in the US. Currently, there are no image-based or light-based FDA cleared or approved tools that use AI for skin cancer detection for any type of healthcare professionals nor for patients. DermaSensor has already delivered on commercializing a product in three regulatory zones abroad and expects to soon launch its product in the United States, following FDA review and clearance.
“The DermaSensor test result helps inform the clinical decisions of frontline providers, resulting in better decisions about when further evaluation is appropriate. This information is helpful in formulating an action plan based upon the level of concern for the lesion in question.” states Dr. Todd Thames, a Board Certified Family Physician, Adjunct Professor of Healthcare Administration at Trinity University, and Medical Advisor to DermaSensor. “Detecting and treating skin cancer early is critical to improving outcomes, reducing suffering and extending life. This is particularly true with aggressive forms of cancer such as melanoma where early identification and intervention has a significant impact on clearance and survival. We are joined with clinicians in helping patients and achieving these goals.”
The DermaSensor device is CE Marked and is commercially available in Australia and New Zealand and is awaiting FDA approval in the United States.
