
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.
| Publishes | Daily | Episodes | 224 | Founded | 8 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | TechnologyLife SciencesScience | |||

This week, we dive into the new medical device regulatory reliance pilot program launched between Malaysia and Thailand. This collaboration creates a powerful fast-track for market access in the ASEAN region, allowing companies to leverage an approva... more
Last week, the U.S. FDA began strict enforcement of new cybersecurity rules for medical devices, catching many global manufacturers by surprise. This sudden shift requires a complete software bill of materials (SBOM) and a proactive security plan, le... more
The U.S. FDA has drawn a new line in the sand for MedTech innovators. With its "refuse to accept" policy now in effect for 510(k) submissions lacking robust cybersecurity measures, the rules for market entry have fundamentally changed. This episode b... more
The European Union has once again extended the transition deadlines for the In Vitro Diagnostic Regulation (IVDR), creating both relief and confusion for diagnostic manufacturers. This episode of MedTech Global Insights breaks down what this latest d... more
In the last week of March, the US FDA dramatically escalated its cybersecurity requirements for wirelessly connected medical devices, creating new, complex hurdles for manufacturers. This move signals a major shift from passive checklists to demands ... more
This week on MedTech Global Insights, we dissect the FDA's groundbreaking announcement of a new AI-powered platform for monitoring adverse events. This move signals a seismic shift from reactive to proactive post-market surveillance, creating a new s... more
The U.S. FDA has just redefined the rules for AI-powered medical software, shifting from one-time approvals to demanding continuous, real-world performance data. This new 'Lifecycle Assurance' approach signals a global trend towards total product lif... more
The U.S. FDA just reclassified a key category of optical diagnostic devices, a move that reshaped the competitive landscape for the entire ophthalmic tech industry last week. This is not just a minor regulatory update; it is a fundamental shift that ... more
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
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Listeners, social reach, demographics and more for this podcast.
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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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MedTech Global Insights launched 8 months ago and published 224 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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Recent guests on MedTech Global Insights include:
1. Pure Global
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