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 10.
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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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ICYMI
The End of Watchful Waiting for AAAs
New device-based interventions for AAA may offer an alternative to prolonged surveillance in treating abdominal aortic aneurysms. Excerpted from our recent MTS feature, "Living Under Surveillance: Can New AAA Treatments Change the Story?"