SciBase has secured an important regulatory update in the United States. The company announced that the U.S. Food and Drug Administration has approved a supplement extending the labelling of Nevisense, allowing additional healthcare professionals — not just dermatologists, to perform the procedure.
This move could significantly improve workflow efficiency and expand access in dermatology clinics.
Previously, the device labelling specified dermatologists only as users. Under the updated approval:
This adjustment enables greater flexibility in how clinics deploy Nevisense.
Dermatology practices often operate under high patient volumes. Delegating measurements to trained staff can:
The update also makes it easier for laboratories performing dermatology-related tests to integrate Nevisense into their service offerings.
According to CEO Pia Renaudin, the expanded labelling supports integration of EIS and Nevisense into the melanoma decision pathway.
Nevisense is a point-of-care diagnostic platform combining:
The system is designed to improve diagnostic accuracy in the early detection of melanoma and other skin disorders.
The platform is built on more than 20 years of research conducted at the Karolinska Institute in Stockholm.
SciBase views this regulatory milestone as part of a larger US expansion strategy. Key growth drivers include:
Together, these developments may strengthen adoption and utilization in the US market.
SciBase is a global medical technology company focused on early detection and prevention in dermatology.
The company develops and commercializes Nevisense to support proactive skin health management and reduce healthcare costs through earlier diagnosis and intervention.
SciBase has been listed on the Nasdaq First North Growth Market since 2015.
By widening the pool of healthcare professionals who can perform Nevisense measurements, SciBase is positioning the device for smoother clinical integration — and potentially broader patient access to AI-assisted melanoma assessment.