FDA Output
FDA Output, July 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in July 2026. Updated July 30.
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Start-Ups
The NASS Innovation Summit: Enthusiasm for Spine Entrepreneurship in a Tough Market
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.
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Regulatory & Reimbursement
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.