Regulatory & Reimbursement
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 20.
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Start-Ups
The Innovation Flow: How Urology’s Leading Society Is Accelerating a New Wave of Innovation
The Innovation Nexus program created by the American Urological Association in 2023 is an innovation ecosystem that connects entrepreneurs, clinicians, investors, and industry partners in mentoring relationships that are mutually beneficial. It’s perhaps one reason why urology is, surprisingly, a hot area of investment right now.
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Pathways’ Pick of the Week
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.