
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 | 252 | Founded | 9 months ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | Life SciencesTechnologyScience | |||

Last week, the US FDA released a bombshell draft guidance for AI/ML-enabled medical devices.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
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
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Apple Podcasts | #111 | |
Apple Podcasts | #223 |









Listeners, social reach, demographics and more for this podcast.
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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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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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Recent guests on MedTech Global Insights include:
1. Pure Global
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