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In this week’s Pathways Picks, Marty Makary resigns from FDA commissioner post under pressure, and the agency’s food chief is elevated to acting role; EU AI Act agreement retains device mandates; UK pushes forward with premarket device legislation; and more regulatory updates from IMDRF, China, Singapore, and FDA.
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.
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.