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Artwork for MedTech Global Insights

MedTech Global Insights

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

PublishesDailyEpisodes243Founded8 months ago
Number of ListenersCategories
Life SciencesTechnologyScience

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Artwork for MedTech Global Insights

Latest Episodes

This week, MedTech Global Insights tackles the monumental shift in the U.S. regulatory landscape: the new Quality Management System Regulation (QMSR). While the FDA’s alignment with ISO 13485 promises global harmony, we uncover the hidden complexitie... more

This week, we dive into the groundbreaking joint guidance on AI/ML medical devices recently released by US and EU regulators. This new framework for Predetermined Change Control Plans (PCCPs) promises to accelerate innovation by allowing pre-approved... more

Last week, the US FDA and CMS announced the TCET pathway, a landmark program to accelerate insurance coverage for innovative medical devices. This move aims to eliminate the notorious "valley of death" where approved devices fail to secure reimbursem... more

This week, we dissect the major regulatory shift in Singapore, as the Health Sciences Authority (HSA) releases groundbreaking new guidance for AI and Machine Learning medical devices. This move tightens the rules on "continuous learning" algorithms a... more

Last week, the European MedTech landscape was thrown into chaos. A major Notified Body was suddenly delisted, leaving hundreds of device manufacturers with invalid CE marks and effectively halting their market access overnight. This episode of MedTec... more

In this episode, we dissect the FDA's monumental decision to regulate Laboratory Developed Tests (LDTs) as medical devices, ending a long-standing policy of enforcement discretion. We explore what this regulatory shift means for the diagnostics indus... more

This episode of MedTech Global Insights unpacks the massive $13.1 billion acquisition of Shockwave Medical by Johnson & Johnson. We explore the groundbreaking sound-wave technology that made Shockwave a prime target and analyze what this deal reveals... more

This week, MedTech Global Insights dives into the sudden regulatory shift from the UK's MHRA, which has enforced a new, stricter framework for AI medical devices. This unexpected announcement creates significant hurdles for global manufacturers, part... 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?

The show centers on the regulatory, technical, and market-access challenges shaping the medical technology landscape. Across episodes, listeners are guided through evolving regulatory frameworks (FDA, ISO standards, and EU MDR/IVDR), cybersecurity mandates, and lifecycle obligations for connected devices and software-enabled therapies. In-depth discussions often highlight practical implications for startups and established players alike, including how to prepare for pre- and post-market scrutiny, document software components, and manage risk while pursuing faster, safer pathways to market. The format tends to pair policy shifts with real-world case studies, such as notable compliance gaps, M&A implications, and the broader impact of AI and ... more

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How many listeners does MedTech Global Insights get?

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How many episodes of MedTech Global Insights are there?

MedTech Global Insights launched 8 months ago and published 243 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

How do I contact MedTech Global Insights?

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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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