FDA Output
FDA Output, August 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in August 2026. Updated August 5.
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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' Picks of the Week: CMS' Severe TAVR Proposal
Industry and hospital groups call out CMS for tightening its proposed coverage policy language for transcatheter aortic valve replacements. Excerpted from Pathways Picks July 23: TEMPO Selection, TAVR Coverage, AI Picks, and India’s Software Guidance.