Regulatory & Reimbursement
FDA Output, May 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in May 2026. Updated May 11.
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Start-Ups
ABILITY Neurotech: Unlocking the Potential of BCI
A Swiss start-up spun out of a leading neuroscience research center brings advanced brain-computer interfaces out of the lab and into patients’ heads to help them overcome the limitations of disability.
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Regulatory & Reimbursement
Pathways' Pick of the Week: Billion-Dollar Budget
User fees would bankroll more than half of the FDA’s FY2027 budget request. Excerpted from Pathways’ Picks April 7: Shuren Venture Fund, MDUFA Agreement, Global Digital Health Updates.