FDA Output
FDA Output, September 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 21.
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Executive Interviews
At UCSF, Spine Surgeon Rajiv Sethi Aims to Scale Value-Based MSK
Rajiv Sethi, who led the Seattle Spine Score initiative to make spine surgery outcomes more consistent and effective, speaks to MedTech Strategist about his move from Virginia Mason in Seattle to UCSF. His expansive new remit includes research and implementation of value-based care initiatives in MSK disorders. One example: a quantitative scoring system he and colleagues are proposing for evaluating new technologies aims to reduce variability and subjectivity in decision making.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: South Korea Eyes Novel Regulatory Routes for AI
MDFS announces its variation on staged approvals for AI. Excerpted from Pathways Picks September 16: TAVR Coverage, New AI Routes, Harmonization Actions, and More.