AI-Enabled Platform Supports Clinical Decision-Making in Melanoma Detection

However, studies show that diagnostic accuracy for cutaneous melanoma using visual assessment alone remains well below 100%. As a result, life-threatening melanomas may be missed while benign lesions are often unnecessarily excised as a precaution. This diagnostic uncertainty underscores the need for decision-support tools. Device-assisted technologies are being introduced to supplement clinical evaluation with objective data and improve diagnostic confidence.

SciBase (Stockholm, Sweden) has received U.S. Food and Drug Administration (FDA) approval of a labeling supplement that extends who may perform the company's Nevisense procedure. Previously, the labeling specified dermatologists as users; it now also includes healthcare professionals such as physician assistants and medical assistants working at dermatology clinics. Under the updated labeling, a dermatologist must initiate the test, while the actual measurement can be performed by these other professionals. 

The Nevisense platform is a unique point-of-care medical tool developed by SciBase to improve diagnostic accuracy in dermatology, specifically for the early detection of melanoma and the monitoring of skin barrier alterations such as atopic dermatitis. It utilizes a non-invasive procedure that combines advanced Electrical Impedance Spectroscopy (EIS) technology with artificial intelligence to provide healthcare professionals with objective, actionable data. Based on over 20 years of research from the Karolinska Institutet, the platform aims to facilitate proactive skin health management and early intervention at the most curable stages of skin cancer.

“This is an important extension of our labelling as it makes it easier to integrate EIS and Nevisense into a clinic's workflow and becoming a part of the melanoma decision pathway. It also means that labs that perform tests now can include Nevisense in their offering. The expanded labelling and the recently published NCCN guidelines together with our ongoing reimbursement work gives me confidence regarding our US potential and growth,” said Pia Renaudin, CEO of SciBase.

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