COOLOGICS Initiates Multi-Center Clinical Trials for Vlisse

grdirks
Apr 10, 2025
1 min read

COOLOGICS, a clinical-stage medical device company, has announced the commencement of new, larger multi-center, open-label clinical trials for its innovative product, Vlisse. These trials will begin this month with the objective of gathering sufficient data to secure FDA clearance for the device. The site initiation visits are already scheduled, during which participating centers will receive comprehensive protocol training to ensure immediate enrollment and adherence to study procedures.

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Comments

Vlisse™ is a Class I Device in the European Union CE Mark Pending and a FDA Class II device pending FDA clearance.