SciBase Gets FDA Nod for AI Skin Scanner
Stockholm-based SciBase has received FDA approval to extend the labeling for its AI-based diagnostic solutions for skin disorders. The approval allows a broader range of healthcare professionals in the U.S. to use the technology.
The newly approved labeling allows trained healthcare professionals, like physician assistants and medical assistants, to perform the Nevisense procedure under the supervision of a dermatologist. This change is intended to better integrate the technology into the clinical workflow of dermatology practices. SciBase's Nevisense platform utilizes Electrical Impedance Spectroscopy (EIS) to analyze skin lesions. The non-invasive, handheld device sends a harmless electrical signal into the skin to measure differences in the electrical properties of skin tissue, which can indicate the presence of cancerous cells. This technology was developed over a 20-year period at the Karolinska Institutet in Stockholm. The device provides an objective analysis to complement a dermatologist's visual assessment of suspicious lesions. By measuring cellular structure, size, and orientation, Nevisense offers additional information to help clinicians decide whether a biopsy is necessary. The technology is backed by extensive clinical research, including what was the largest prospective study in melanoma detection. In its pivotal study, the Nevisense system demonstrated a high sensitivity of 97% in detecting melanoma, meaning it is effective at correctly identifying malignant lesions. The study also showed a 100% sensitivity for nonmelanoma skin cancers like basal cell and squamous cell carcinomas. This recent FDA approval is the latest for SciBase, which first received pre-market approval for Nevisense in the U.S. in 2017. A third-generation version of the device, Nevisense 3.0, was approved by the FDA in May 2020. In addition to melanoma, SciBase has developed applications for its EIS technology to assess non-melanoma skin cancer and the skin's barrier function, with a portable pen-sized version of the device called Nevisense Go aimed at research and new applications.
