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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.
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.
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.