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ONWARD Medical Receives FDA IDE Approval to Initiate the Empower BP Pivotal Study with the ARC-IM System
Globenewswire· 2025-08-18 16:30
THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) The investigational device exemption (IDE) allows initiation of a global pivotal study designed to assess the safety and efficacy of the ARCIM System®, an implantable neurostimulation technology developed to address blood pressure instability after spinal cord injury (SCI).Managing blood pressure instability is a major unmet need after SCI, with a significant impact on cardiov ...