Regulatory & Reimbursement
FDA Output, March 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in March 2025. Updated March 25, 2025.
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Start-Ups to Watch
GrayMatters Health Gives Patients Control With Noninvasive PTSD Treatment
An Israeli start-up’s clever method for making gold-standard neuromodulation therapy more accessible gives patients the power to learn to regulate brain activity associated with PTSD.
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Pathways' Picks
Pathways' Pick of the Week: Trump Era’s First De Novo
FDA authorized its first De Novo in the Trump era. Excerpted from Pathways’ Picks March 26: MDR Reform Input Streams In, Makary Confirmed at FDA, and More.