SciBase Holding AB, a developer of artificial intelligence-based diagnostic solutions for skin disorders, has received approval from the U.S. Food and Drug Administration to expand the labelling of its Nevisense device. The updated approval allows additional healthcare professionals, such as physician assistants and medical assistants working in dermatology clinics—to perform the Nevisense procedure.

Previously, the device’s labelling specified that only dermatologists could conduct the test. Under the revised guidelines, a dermatologist must still initiate the procedure, but the actual measurement can now be carried out by other qualified healthcare professionals. The change is expected to streamline clinical workflows and facilitate easier integration of Nevisense into routine dermatology practice.

Nevisense uses Electrical Impedance Spectroscopy (EIS) technology to support clinicians in the assessment of suspicious skin lesions as part of the melanoma decision-making pathway. By broadening the pool of professionals who can perform the measurement, SciBase aims to enhance patient access and improve utilisation across dermatology clinics and testing laboratories.

Commenting on the development, Pia Renaudin, CEO of SciBase, said the expanded labelling makes it easier to integrate EIS and Nevisense into clinical workflows and strengthens the company’s position in the US market. She added that the updated approval, along with recently published NCCN guidelines and ongoing reimbursement initiatives, reinforces confidence in the company’s growth potential in the United States.