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 13.
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Business Strategies
Can Integra Life Sciences Regain Trust?
After several ultra-challenging years for Integra LifeSciences, Chair and shareholder Stuart Essig is stepping back into the CEO role, with ambitions to accelerate the company’s turnaround. Wall Street remains wary, despite Essig’s previous successes.
Start-Ups
The NASS Innovation Summit: Enthusiasm for Spine Entrepreneurship in a Tough Market
Business Strategies
Precision Diagnostics Is Having a Moment: Canaccord’s Kyle Mikson Explains the Catalysts, Trends, and Competitive Landscape
Start-Ups
The Innovation Flow: How Urology’s Leading Society Is Accelerating a New Wave of Innovation
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Regulatory & Reimbursement
Pathways' Pick of the Week: America-First User Fees
FDA provides more details on the draft MDUFA VI agreement. Excerpted from Pathways Picks July 15: America First" Fees, Remote Monitoring Restrictions, Aussie Advertising Code, and More.