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In this week’s Pathways Picks: FDA takes step toward mandatory electronic PMAs; congressional watchdog looks at FDA third party reviewers; an advisory panel support GRAIL’s cancer-screening PMA; FDA commissioner nominee heads to the Hill; China issues guides on AI clinical evaluation, good manufacturing practices, and real world data quality; and more medtech policy updates.
Coronary microvascular disease can contribute to major cardiovascular pathology, but there are no approved disease-modifying therapies. On the hunt for a new solution, VahatiCor is pursuing a new device that narrows coronary sinus flow to improve perfusion in the microvascular network.
New funding from for the agency’s ADVOCATE program. Excerpted from Pathways Picks September 9: FDA Taps Tech Chief, Key Staffer Departs, EU Procurement Reform, and More.