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In this week’s Pathways Picks: Industry groups explain why tariffs are counterproductive and propose a streamlined regulatory/reimbursement path tied to domestic operations; US and European physician groups engage on AI; Europe finalizes EU-wide HTA rules for devices; CMS recalls staff; India software guidance; South Korea streamlines manufacturing reviews, and more from the UK, Europe, and Brazil.
The AAC just issued a scientific consensus statement on the link between inflammation and coronary artery disease and the importance of risk assessments based on that clinically actionable biomarker. Caristo Diagnostics is already on it, with an AI platform that can identify inflamed vessels from conventional CCTA scans.
Apple receives 510(k) clearance for its new Apple Watch Hypertension Notification Feature. Excerpted from Pathways’ Picks September 17: CMS Departure, Apple 510(k) Questions, PCCPs on the Rise, and More.