SciBase receives approval by FDA for extended labelling in the US
STOCKHOLM, Sweden - March 2, 2026 - SciBase Holding AB ("SciBase") [STO: SCIB], a leading developer of AI-based diagnostic solutions for skin disorders, today announced that it has received approval by FDA for its supplement to extend the labelling to include other healthcare professionals and not only dermatologists to perform the Nevisense procedure. Previously, the labelling only specified dermatologists as users but now it also includes healthcare professionals such as physician assistants and medical assistants working at dermatology clinics. A dermatologist still needs to initiate the test, but the actual measurement can now be performed by other healthcare professionals. This means that Nevisense now much easier can be integrated into a clinic's workflow thus potentially expanding SciBase customer utilization and easier access for patients.
"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.
For further information please contact:
Pia Renaudin, CEO,
Phone. +46732069802
E-mail: pia.renaudin@scibase.com
Certified Advisor (CA):
DNB Carnegie Investment Bank AB (publ)
Tel: +46 8 588 68 570
E-mail: certifiedadviser@carnegie.se
About SciBase and Nevisense
SciBase is a global medical technology company, specializing in early detection and prevention in dermatology. SciBase develops and commercializes Nevisense, a unique point-of-care platform that combines AI (artificial intelligence) and advanced EIS technology to enhance diagnostic accuracy, ensuring proactive skin health management.
Our commitment is to minimize patient suffering, allowing clinicians to improve and save lives through timely detection and intervention and reduce healthcare costs.
Built on more than 20 years of research at Karolinska Institute in Stockholm, Sweden, SciBase is a leader in dermatological advancements.
The company has been on the Nasdaq First North Growth Market exchange since June 2, 2015 and the company's Certified Adviser is DNB Carnegie Investment Bank AB (publ). Learn more at www.scibase.com. For press releases and financial reports visit: http://investors.scibase.se/en/pressreleases
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