FDA Output, September 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 10.
Quickly uncover the breadth and depth of the editorial offerings found only in MedTech Strategist and Market Pathways – the medtech industry’s leading sources of global business, regulatory, and reimbursement analysis and intelligence on an all-in-one, digital platform. Think Strategically. Subscribe Today
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in September 2026. Updated September 10.
At a NASS Summit on Spine Innovation, battle-hardened entrepreneurs, surgeons, investors, and healthcare system executives discussed lessons learned and takeaways for building companies in a financially constrained environment.
The country amends its regulations to further rely on EU CE marks, and makes other simplifications. Excerpted from Pathways Picks August 26: India Harmonization, Digital Health Updates, FDA Home Challenge, and More.