FDA Output
FDA Output, July 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in July 2026. Updated July 30.
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Business Strategies
Precision Diagnostics Is Having a Moment: Canaccord’s Kyle Mikson Explains the Catalysts, Trends, and Competitive Landscape
The precision oncology market is estimated to be $80-100 billion, with less than 20% penetration. In a video interview, Kyle Mikson of Canaccord Genuity explains how top competitors like Guardant Health, Natera, Grail, Tempus, GeneDx, and others are set to benefit and the catalysts driving adoption.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Alternative Pathway Still on the Chopping Block
CMS reiterates its plan to cancel the streamlined path. Excerpted from Pathways’ Picks June 8: MDUFA Agreement, Medicare Plans, EU Parliament Response, and More.