Market Pathways | MedTech Regulatory & Policy

⚕ MedTech regulatory, reimbursement and #policy made easy. We are global medical device market-access experts researching, writing and sharing the knowledge you need to keep you informed and ahead of your competition in the #medtech industry.

Postmarket surveillance is evolving fast. Regulators now expect manufacturers to actively analyze device safety data, not just submit it. Read more here: bit.ly/4doCmYV #medtech

Three novel FDA device actions and multiple Class I recalls marked the first half of May 2026. Our latest #FDA Output roundup tracks approvals, recalls, warning letters, and more: bit.ly/4tsfVHY

Faster coverage is the goal, but questions remain. @FDADeviceInfo and @CMSGov introduce RAPID to align approval and #Medicare coverage for Breakthrough Devices. Industry is watching closely as details unfold: bit.ly/4d8cvEp #medtech

The shift is here, and many aren’t ready. Regulators are now analyzing device safety data and expect manufacturers to do the same. Why 2026 is a turning point for surveillance: bit.ly/4euIj8F #medtech

Where do companies fail MOST after #FDA? • #Reimbursement gaps • Weak commercialization • Not enough payer data • Investor drop-off ~115 TAP devices aimed to fix this. What’s the real issue?

If you can’t explain the #medtech landscape, you’re already behind. Market Pathways gives you the insight on global regulation, #reimbursement, and policy so you can speak with confidence. Start your free trial today: bit.ly/4w5fyFQ

Back from lunch at #InnovationDublin 2026. Now live: is the #medtech public market still viable, or is M&A the only path? Experts from @ThisIsBTIG, @Piper_Sandler, @Market_Pathways, and more break down capital markets, deal activity, and investor sentiment.

How are #medtech innovators funding growth in today’s shifting landscape? Happening now at #InnovationDublin 2026, this panel with leaders from @ClaretCapital, @Market_Pathways, and more explores public, private, and patient capital strategies.

FDA and CMS have proposed a parallel review program to expedite certain Class II and Class III breakthrough medical devices to market for Medicare patients called the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. hubs.la/Q04dr9-p0

Today FDA approved the first-ever gene therapy for the treatment of genetic hearing loss under the National Priority Voucher Program. ✅6th approval under the National Priority Voucher Program ✅Approved 61 days after filing fda.gov/news-events/pr…

Leading in #medtech starts with insight. Market Pathways delivers global analysis on #regulatory, reimbursement, and policy trends so you can stay ahead and make smarter decisions: bit.ly/4u3m9ie

Struggling with #MDR/IVDR classification? The updated EU Borderline & Classification Manual (v5, April 2026) offers key guidance. Explore it and access more in Pathways’ Document Depot: bit.ly/4dZDRyB

This week: HHS Secretary Kennedy hints about work on Breakthrough Device coverage policies; Kenya publishes a forward-leaning #AI guidance; Europe updates its guides on risk classifications and borderline products; and more: bit.ly/48RRhsX

#FDA approval is only half the battle. Learn how to accelerate the path to #reimbursement with leaders from @CMSGov, @proverummedical, @SUBiodesign, @Market_Pathways, and more at #InnovationDublin. Join our expert panel April 28 in Dublin: bit.ly/4cFURrm

NTAP awards hit record highs, driven by the Breakthrough Device pathway. Now @CMSGov may end it. What could this mean for #medtech innovation and #reimbursement? bit.ly/4e0sIgR

#ICYMI: What’s shaping #medtech policy right now? The latest Market Pathways digital edition covers AI software rules, MDR updates, @bostonsci #reimbursement strategy, and expert insights. Read more: bit.ly/4sLHFqY

How fast will MDR/IVDR reforms move? EU leaders signal urgency, but no clear timeline. MEP Tomislav Sokol highlights the challenge of balancing speed with complex negotiations: bit.ly/4tkLxA0 #medtech

What happens after #FDA approval? Former CDRH leaders are launching White Oak 66 Capital to tackle post-FDA risk, focusing on #reimbursement and market access from day one: bit.ly/4efq4UA

The NTAP surge may be ending. #CMS plans to remove the Breakthrough Device pathway and require proof of clinical improvement, potentially reducing awards and reshaping #reimbursement strategy: bit.ly/3OcT44R

The #medtech regulatory landscape is evolving fast. Stay ahead with Market Pathways, delivering global insights on regulation, #reimbursement, and market access: bit.ly/4ckhRM9