@Market_Pathways

Exploring the people, challenges, and opportunities impacting the global #medtech regulatory, reimbursement and policy communities. Likes,RTs,etc ≠ endorsement.

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Joined April 2019
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⚕ 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.
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1 new EU decision marks a milestone in AI regulation. Implementing Decision (EU) 2026/2274 introduces the first harmonised #AI Act standard focused on quality management systems. Get more access to docs like this from Pathways' Document Depot: bit.ly/4iv111t
1 new EU decision marks a milestone in AI regulation. Implementing Decision (EU) 2026/2274 introduces the first harmonised #AI Act standard focused on quality management systems. Get more access to docs like this from Pathways' Document Depot: https://bit.ly/4iv111t

ALT 1 new EU decision marks a milestone in AI regulation. Implementing Decision (EU) 2026/2274 introduces the first harmonised #AI Act standard focused on quality management systems. Get more access to docs like this from Pathways' Document Depot: https://bit.ly/4iv111t

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With over 4,000 documents available, staying informed about global #medtech regulations has never been more convenient. Explore global medtech regulations and policy updates with Pathways' improved Document Depot: bit.ly/3Uz1K8M

Document Depot: The Medtech Policy Database

https://www.mystrategist.com/market-pathways/article/document_depot...

youtube.com
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5 free #medtech cheat sheets covering regulatory updates, reimbursement challenges, MDUFA VI, and more. Get key takeaways from our top 2025 articles: bit.ly/4BfIQUV
5 free #medtech cheat sheets covering regulatory updates, reimbursement challenges, MDUFA VI, and more. Get key takeaways from our top 2025 articles: https://bit.ly/4BfIQUV

ALT 5 free #medtech cheat sheets covering regulatory updates, reimbursement challenges, MDUFA VI, and more. Get key takeaways from our top 2025 articles: https://bit.ly/4BfIQUV

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Market Pathways | MedTech Regulatory & Policy retweeted
JAMA Internal Medicine@JAMAInternalMedOct 18
The 2025 #NIH Public Access Policy may still leave NIH-funded investigators facing new article processing charges for immediate public access, with an estimated upper-bound annual cost of more than $100 million. ja.ma/4hpzzSm

Cost of Article Processing Charges to Adhere to Public Access Policy

This economic evaluation estimates investigator payments of article processing charges to journal publishers to allow immediate public access to their published federally funded research.

jamanetwork.com
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EU MDR reform is in the spotlight. 3 reasons to listen: • Understand potential changes • Hear expert insights • Stay ahead of #regulatory developments Listen here: bit.ly/4zmp7kK
EU MDR reform is in the spotlight. 3 reasons to listen: • Understand potential changes • Hear expert insights • Stay ahead of #regulatory developments Listen here: https://bit.ly/4zmp7kK

ALT EU MDR reform is in the spotlight. 3 reasons to listen: • Understand potential changes • Hear expert insights • Stay ahead of #regulatory developments Listen here: https://bit.ly/4zmp7kK

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Market Pathways | MedTech Regulatory & Policy retweeted
MedTech Strategist | MedTech's Most Trusted Source@MedTechStratOct 15
.@MedTechStrat, @Market_Pathways, and the #medtech community are already making plans for Boston. Come meet some members of our team at Booth #1136 at #MedTechCon:
.@MedTechStrat, @Market_Pathways, and the #medtech community are already making plans for Boston. Come meet some members of our team at Booth #1136 at #MedTechCon:

ALT .@MedTechStrat, @Market_Pathways, and the #medtech community are already making plans for Boston. Come meet some members of our team at Booth #1136 at #MedTechCon:

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1 new #FDA final order for infant monitoring #medicaldevices. The agency has codified Class II requirements for OTC pulse rate and oxygen saturation monitors. Get access to more docs like this here: bit.ly/4B9luR0
1 new #FDA final order for infant monitoring #medicaldevices. The agency has codified Class II requirements for OTC pulse rate and oxygen saturation monitors. Get access to more docs like this here: https://bit.ly/4B9luR0

ALT 1 new #FDA final order for infant monitoring #medicaldevices. The agency has codified Class II requirements for OTC pulse rate and oxygen saturation monitors. Get access to more docs like this here: https://bit.ly/4B9luR0

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FDA QMSR and EU MDR take different approaches to residual risk. Learn how manufacturers can align risk management across both markets. Read more: bit.ly/4zPQ3tx #medtech Source: FDA QMSR; EU MDR 2017/745
FDA QMSR and EU MDR take different approaches to residual risk. Learn how manufacturers can align risk management across both markets. Read more: https://bit.ly/4zPQ3tx #medtech Source: FDA QMSR; EU MDR 2017/745

ALT FDA QMSR and EU MDR take different approaches to residual risk. Learn how manufacturers can align risk management across both markets. Read more: https://bit.ly/4zPQ3tx #medtech Source: FDA QMSR; EU MDR 2017/745

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What is the biggest #regulatory challenge facing #medtech companies today?
0%FDA Requirements
0%Regulatory Changes
100%Global Approvals
0%Compliance vs. Innovation
1 votes • Final results
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From evolving FDA requirements to navigating global regulatory frameworks, medtech companies face an increasingly complex regulatory landscape. Explore more regulatory insights from Market Pathways: bit.ly/4yhlQ5g

Market Pathways — MedTech Strategist

Stay ahead of the competition with the medical device industry's most trusted strategic publications: MedTech Strategist and Market Pathways, a global regulatory, reimbursement and policy review.

medtechstrategist.com
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Your free Market Pathways feature article is ready. 📖 Explore what a new administration could mean for the #medtech industry: bit.ly/3TrgCpj
Your free Market Pathways feature article is ready. 📖 Explore what a new administration could mean for the #medtech industry: https://bit.ly/3TrgCpj

ALT Your free Market Pathways feature article is ready. 📖 Explore what a new administration could mean for the #medtech industry: https://bit.ly/3TrgCpj

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Market Pathways | MedTech Regulatory & Policy retweeted
Regulatory Affairs Professionals Society@RAPSorgOct 8
The European Medicines Agency's Committee for Medicinal Products for Human Use is planning to update a 2018 guideline on good pharmacogenomic practices. hubs.la/Q04zBkY50

EMA plans major update to pharmacogenomics guideline

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than...

raps.org
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#ICYMI: There’s plenty happening across the #medtech policy landscape. Catch up on RAPID, EU Joint Clinical Assessments, MDUFA VI, NTAP updates and more in the latest Market Pathways digital edition: bit.ly/4yxBv13
#ICYMI: There’s plenty happening across the #medtech policy landscape. Catch up on RAPID, EU Joint Clinical Assessments, MDUFA VI, NTAP updates and more in the latest Market Pathways digital edition: https://bit.ly/4yxBv13

ALT #ICYMI: There’s plenty happening across the #medtech policy landscape. Catch up on RAPID, EU Joint Clinical Assessments, MDUFA VI, NTAP updates and more in the latest Market Pathways digital edition: https://bit.ly/4yxBv13

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Stop digging through agency websites for the #medtech docd you need. Pathways' Document Depot lets you search and filter thousands of #regulatory and market access documents from agencies around the world. Learn how to navigate the new Doc Depot: bit.ly/4xZ4Bp7

Document Depot: The Medtech Policy Database

https://www.mystrategist.com/market-pathways/article/document_depot...

youtube.com
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Market Pathways | MedTech Regulatory & Policy retweeted
Regulatory Affairs Professionals Society@RAPSorgOct 6
Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans tops the to-do list for the FDA Center for Devices and Radiological Health for fiscal year 2027.. hubs.la/Q04zg7Dk0

FDA’s device center releases guidance agenda for FY 2027

Finalizing guidance on artificial intelligence-enabled devices throughout their product lifecycle and on pre-determined change control plans (PCCPs) tops the to-do list for the US Food and Drug...

raps.org
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25 years of CMS insight, plus major shifts in Medicare coverage and #reimbursement. Our latest article pack explores what medtech professionals should know about CMS, evidence, payment and patient access. Here are the links below:
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Cardiac Ablation in More Places: Medicare Expands EP Access to Surgical Centers: bit.ly/4hJx10e
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What I Learned From 25 Years at CMS: An Interview With Tamara Syrek Jensen: bit.ly/474OPxZ
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