MedTech Global Insights
Ran Chen
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Pure Global: US AI MedTech Rules & The Global Fallout.
Last week, the US FDA released a bombshell draft guidance for AI/ML-enabled medical devices.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…
Pure Global: USA's LDT Overhaul - Navigating the FDA's New IVD Era
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…
USA MedTech M&A: Pure Global on The Deal Frenzy of 2026.
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…
Pure Global: US Cyber Rules & The MedTech Rejection Wave
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…
EU's AI-MDR Maze: Pure Global on Dual Regulation Traps
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…
Pure Global: US/EU AI Imaging & The Dual-Approval Gambit
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…
USA 510(k) Cybersecurity: Pure Global on the New Hidden Hurdles
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…
US FDA's Cyber Rules: Pure Global on Life Beyond the SBOM
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…
Pure Global: US MedTech's Secret Path from FDA Nod to Sales
In this episode, we dissect the groundbreaking new program from the FDA and CMS that bridges the gap between regulatory approval and Medicare reimbursement in the United. States. This policy shift is…
USA's QMS Shift: Pure Global on ISO 13485's Hidden Landmines
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…
USA-EU AI MedTech: Pure Global on the New 'PCCP' Regulation Trap
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)…
US MedTech's Money Maze: Pure Global on New CMS Rules
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…
Singapore AI MedTech: Cracking the Algorithm Code | Pure Global
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…
Pure Global: Brussels' MedTech Crisis - Surviving a CE Mark Shutdown
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…
Pure Global: USA's New IVD Regulatory Maze After LDT Ruling
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…
Pure Global: Silicon Valley's Cardio Tech Endgame
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…
UK AI MedTech Chaos: Pure Global's Guide to the New Rules
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…
Pure Global: UK/US Fast-Track, The MedTech Alliance's Hidden Hurdles
This week on MedTech Global Insights, we dissect the major announcement of a new regulatory alignment between the UK's MHRA and the US FDA. This move could potentially reshape market access…
Pure Global: US QMSR Gaps Beyond ISO 13485 Compliance
This week, we dive into the most significant shift in U.S. MedTech regulations in years: the FDA's new Quality Management System Regulation (QMSR). While it harmonizes with the global ISO 13485…
Pure Global: US FDA's Cancer Device Win & The Hurdle Beyond
This week, we dissect the groundbreaking FDA approval of a first-of-its-kind device for pancreatic cancer. This new technology, which combines focused ultrasound with AI targeting, offers new hope…
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MedTech Global Insights has published 252 episodes since August 2025, covering topics in Business, Life Sciences.
MedTech Global Insights is currently dormant with new episodes daily. Average episode length is 2m.
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