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Keeping up with global #medtech policy isn’t easy. Download five of the most-read Market Pathways | MedTech Regulatory & Policy articles from 2024—free. Get timely insights on #reimbursement, international trends, and market access strategy. Get the pack: bit.ly/4kuaZPu

FDA launches agency-wide AI tool ‘Elsa’ ahead of schedule. hubs.la/Q03qnMyX0

"Honored to moderate 'Why Europe Matters?' at #MedtechForum in Lisbon—an insightful conversation on EU device regulation with top investors: Janke Dittmer, Craig Cooper, Giovanni Monti & Xavier Bertrand. Grateful to all. See you next year in Stockholm!" — Stephen Levin | Expert MedTech Insight & Analysis

Can a continent as diverse as Africa speak with one #regulatory voice? With 30+ countries backing the African Medicines Agency, harmonized #medtech regulation is becoming reality. Paulyne Wairimu (Paulyne Wairimu) shares what’s next for AMA, AMDF & device oversight:

FDA Cuts, #AI Tool, 510(k) Guide, Mexico Streamlines, and More In this week’s Pathways Picks: FDA’s FY 2026 budget proposal would increase device funding but cut staff, including user fee-supported employees; Small Business Determination backlog; the agency launches an AI tool

How do you renegotiate #FDA user fees when trust, staffing, and science are all under pressure? As talks begin under a Trump admin and RFK Jr.-led HHS, experts like Grace Graham, Katlin McKelvie, and Eva Temkin weigh tough trade-offs. A leaner #MDUFA is likely—but not without

"Thank you to Lifeblood for bringing together an informed panel on current financing and development issues facing #MedTech companies. Really enjoyed the stimulating conversation with Paul Grand and MedTech Innovator, Ken Nelson and Medtech Advantage fund, and Joseph Snyder and

Keeping up with various agencies and customer rules when crafting regulatory and medical documents can be difficult. Join this interactive workshop to learn more. Save your spot today: hubs.la/Q03qVTh20

What role does Italy play in EU #medtech regulation? With more MDR-designated notified bodies than any other EU country, Italy is a key #regulatory hub. Health Minister Orazio Schillaci’s team also helped shape the European Medical Device Nomenclature now used across MDR and

South Korea is setting a new global standard in #digitalhealth. With 11 new documents in May, its Digital Medical Products Act lays the groundwork for smarter regulation of AI, SaMD, #VR, and more. Could this be a model for others? Full story: bit.ly/4kwvQ4t

FDA’s warning letters cite firms over inadequate testing, BIMO violations. hubs.la/Q03rdMBC0

Would you risk losing $20K to stay on schedule? Startups are stuck waiting as #FDA delays small business fee reviews. With no refund if the discount comes late, many face a costly dilemma. Read more: bit.ly/3Fwhq5n

What does it take to unify #medtech regulation across 55 countries? Africa is launching the African Medicines Agency to centralize oversight of #medicaldevices, drugs, and diagnostics—backed by global alignment and local resilience: bit.ly/3HPbk0n

New EU rules for Joint Clinical Assessments are on the table. Will your team be ready? The European Commission’s draft lays out the process, roles, and templates for device & diagnostic evaluations. Comments due June 25. Read it now: bit.ly/45gXSfz Explore the Doc Depot:

Curious how U.S. policy shifts could impact medtech? Market Pathways is offering a complimentary feature article: “What Does a New Administration Mean for MedTech?”—a must-read for #regulatory, strategy, and policy professionals. Claim your free download today and get insights

#ICYMI: Updated June 12. Novel #FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in June 2025. Here's a roundup of FDA’s actions in June 2025: bit.ly/4e0Jx9g

Looking to stay ahead in #medtech policy, regulation, and reimbursement? Market Pathways offers expert insights and timely updates for industry decision-makers. Explore the latest issue: bit.ly/407dlv8

The Trump administration’s FY 2026 FDA budget request proposes more money for #medicaldevices—yet slashes over 400 staff positions, including user fee-funded roles. What does this mean for #FDA's device program? Market Pathways | MedTech Regulatory & Policy breaks it down: bit.ly/4jUZYFH

What’s next for #FDA user fees as staffing cuts and political pressure mount? With MDUFA VI talks underway, experts are questioning how science-based reviews and patient access will hold up. Full breakdown from Market Pathways: bit.ly/4e4kTF1

The only tool of its kind in #medtech: Pathways’ Document Depot gives you searchable access to global rules, guidance, and more. 📌 Latest: Korea premarket consult doc + new FDA 510(k) + hernia mesh draft guidances. 🔎 bit.ly/4ldpcAJ