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MedTech Global Insights

Ran Chen
FDA
Medical Devices
Cybersecurity
Pure Global
Artificial Intelligence
European Union
Regulatory Compliance
Brazil
Medtech
ANVISA
ISO 13485
Post-Market Surveillance
Regulatory Strategy
Medical Device Regulation
Quality Management System Regulation
Singapore
Risk Management
Software Bill Of Materials
Software As a Medical Device
Global Market Access

What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.

PublishesDailyEpisodes252Founded9 months ago
Number of ListenersCategories
Life SciencesTechnologyScience

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Latest Episodes

Last week, the US FDA released a bombshell draft guidance for AI/ML-enabled medical devices. This isn't just another update; it's a fundamental shift towards a total lifecycle regulatory model. This new framework, centered on Predetermined Change Con... more

The U.S. FDA has just sent shockwaves through the diagnostics industry with a final rule to regulate Laboratory Developed Tests (LDTs) as medical devices. This decision eliminates decades of regulatory ambiguity and forces thousands of clinical labor... more

The start of 2026 has been marked by a huge wave of multi-billion dollar mergers and acquisitions in the MedTech industry. Giants like Abbott and Boston Scientific are spending big to acquire innovators in diagnostics and neurovascular tech, fundamen... more

The FDA has drawn a new line in the sand for medical device cybersecurity. Since March 2024, the "Refuse to Accept" policy is in full effect, turning premarket submissions into a high-risk gamble for unprepared manufacturers. In this episode, we diss... more

The European Commission has just released critical new guidance on how the EU AI Act and the Medical Device Regulation (MDR) will work together. This creates a new reality of dual regulation for MedTech innovators, fundamentally changing the requirem... more

This week on MedTech Global Insights, we dissect a major strategic win in the cardiovascular space. Abbott's recent dual-market approval for its AI-powered imaging software in both the U.S. and Europe is more than just a headline—it's a blueprint for... more

The US FDA's 510(k) pathway has fundamentally changed in 2026. What was once a straightforward process for many devices has now evolved with complex new requirements for cybersecurity and the use of Real-World Evidence. This episode breaks down the c... more

The U.S. FDA has just released transformative new guidance on medical device cybersecurity, moving it from a final-stage checklist to a core requirement throughout the entire product lifecycle. This shift demands a radical new approach, integrating a... more

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Recent Guests

Pure Global
A firm providing regulatory consulting services in Brazil for MedTech companies
Pure Global
Episode: Unlocking Brazil's MedTech Market: Your Guide to ANVISA Compliance and Finding the Best Regulatory Consulting Firm with Pure Global

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Frequently Asked Questions About MedTech Global Insights

What is MedTech Global Insights about and what kind of topics does it cover?

Listeners tune in to understand how regulatory, reimbursement, and market-access dynamics shape the global MedTech landscape. Across episodes, the focus centers on AI-enabled medical devices, cybersecurity and data governance, regulatory pathways in the US and EU, and how mergers, partnerships, and reimbursement reforms influence time-to-market and post-market strategy. Noteworthy themes include the Predetermined Change Control Plan (PCCP) and lifecycle governance for AI in medical devices, cross-border regulatory harmonization challenges, and practical guidance for navigating reimbursement pathways like TCET in the US. The show is likely to appeal to product leaders, regulatory professionals, investors, and executives seeking concrete impl... more

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How many episodes of MedTech Global Insights are there?

MedTech Global Insights launched 9 months ago and published 252 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on MedTech Global Insights?

Recent guests on MedTech Global Insights include:

1. Pure Global

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