U.S., April 22 -- ClinicalTrials.gov registry received information related to the study (NCT07543406) titled 'MINDZ-- Minimally Invasive Approach Pilot Study' on April 09.
Brief Summary: This clinical investigation is a pilot, first-in-human (FIH) study designed to demonstrate proof of concept, safety, and functional performance of the MINDZ subdural electrode grid when used in relevant neurosurgical settings. The study will provide initial clinical evidence to support future conformity assessment and CE marking under the European Medical Device Regulation (MDR).
The investigational device, MINDZ, developed by Neurosoft Bioelectronics, is a novel, soft and highly conformable subdural electrode grid designed for minimally invasive implanta...