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FDA grants IDE approval for NextBioMedical’s Nexsphere-F trial
The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE ... The multi-centre, open-label RESORB trial will focus on providing a ‘sustainable’ and ...
The Victoria Advocate17d
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
MILAN, Feb. 5, 2025 /PRNewswire/ -- Newronika, the developer of groundbreaking adaptive deep brain stimulation technology, is proud to announce the receipt of an Investigational Device Exemption ...
PathMaker Neurosystems Announces IRB Approval for DoD-funded Clinical Trial of the MyoRegulator Device in ALS
Nader Yaghoubi, M.D., Ph.D., PathMaker’s Co-Founder and CEO, stated, “We are pleased to announce IRB approval for the CALM study, which allows us to commence enrollments shortly. Given the mechanisms ...