Regulatory & Reimbursement
FDA Output, May 2026
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in May 2026. Updated May 25.
Welcome to MyStrategist
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
Start a free trial and unlock 5-days of exclusive subscriber-only access to MedTech Strategist & Market Pathways
Start Trial
Providers & Payors
In a Post-Inpatient Only Rule World, Tight ASC Margins, More Surgeon Choice
MS has eliminated all orthopedic procedures from the inpatient-only rule, as of January 1, 2026—part of a three-year plan to remove the list entirely--and is working on other policy changes that expand access to lower-cost ambulatory surgery centers. Experts highlight how these changes will affect manufacturers’ commercial strategies and influence ASC procurement in ways that both incentivize and discourage adoption of high-cost technologies.
Don't Just Advertise... Strategize!
Advertise with MedTech Strategist and be seen by medtech's most influential executives.
Learn More
Pathways’ Pick of the Week
Pathways' Pick of the Week: Bundled Payments for Joint Replacements
CMS advances novel payment models in orthopedics. Excerpted from Pathways’ Picks April 15: New Medicare Directions, AI Picks, and Global Regulatory Updates