FDA Output
FDA Output, October 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in October 2026. Updated October 31.
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Start-Ups
MedTech Catapult: A Springboard to MedTech Innovation in Singapore
Singapore possesses many of the capabilities needed to build successful medtech companies. MedTech Catapult, a national platform hosted by the Agency for Science, Technology and Research (A*STAR), Singapore’s lead public sector R&D agency, aims to connect and build upon these strengths to accelerate promising innovations toward commercial success, and, in the process, to further strengthen Singapore’s medtech ecosystem.
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Regulatory & Reimbursement
Pathways' Pick of the Week: FDA Plans First GenAI Guidance
FDA drafts mental health generative AI guidance. Excerpted from Pathways Picks October 7: AI Plans in the UK and US, Europe’s First JCA Devices, and More.