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In this week’s Pathways Picks: Malaysia and Singapore sign a regulatory reliance agreement; China drafts real-world data standards; a guide on stents from South Korea and one on AI/ML from South Africa; Chile bulks up device program with new funding; Canada launches new eSTAR submission pilot; researchers study recalls in FDA-cleared AI devices; and more from the US, Europe, and China.
On the heels of Fasikl’s successful TRANQUIL study, FDA approves its combination of sophisticated AI and non- to minimally invasive stimulation.
The Trump administration delays ethylene oxide emission compliance for device companies. Excerpted from Pathways’ Picks July 23: Trump’s AI Plan, Global Reliance, Africa, Asia, and EU Updates.