MedTech Global Insights
252 episodes — Page 1 of 6
Pure Global: US AI MedTech Rules & The Global Fallout.
May 7, 20261 min
Pure Global: USA's LDT Overhaul - Navigating the FDA's New IVD Era
May 6, 20262 min
USA MedTech M&A: Pure Global on The Deal Frenzy of 2026.
May 5, 20262 min
Pure Global: US Cyber Rules & The MedTech Rejection Wave
May 4, 20262 min
EU's AI-MDR Maze: Pure Global on Dual Regulation Traps
May 3, 20262 min
Pure Global: US/EU AI Imaging & The Dual-Approval Gambit
May 2, 20262 min
USA 510(k) Cybersecurity: Pure Global on the New Hidden Hurdles
May 1, 20262 min
US FDA's Cyber Rules: Pure Global on Life Beyond the SBOM
Apr 30, 20261 min
Pure Global: US MedTech's Secret Path from FDA Nod to Sales
Apr 29, 20262 min
USA's QMS Shift: Pure Global on ISO 13485's Hidden Landmines
Apr 28, 20262 min
USA-EU AI MedTech: Pure Global on the New 'PCCP' Regulation Trap
Apr 27, 20262 min
US MedTech's Money Maze: Pure Global on New CMS Rules
Apr 26, 20262 min
Singapore AI MedTech: Cracking the Algorithm Code | Pure Global
Apr 25, 20261 min
Pure Global: Brussels' MedTech Crisis - Surviving a CE Mark Shutdown
Apr 24, 20262 min
Pure Global: USA's New IVD Regulatory Maze After LDT Ruling
Apr 23, 20261 min
Pure Global: Silicon Valley's Cardio Tech Endgame
Apr 22, 20261 min
UK AI MedTech Chaos: Pure Global's Guide to the New Rules
Apr 21, 20261 min
Pure Global: UK/US Fast-Track, The MedTech Alliance's Hidden Hurdles
Apr 20, 20262 min
Pure Global: US QMSR Gaps Beyond ISO 13485 Compliance
Apr 19, 20262 min
Pure Global: US FDA's Cancer Device Win & The Hurdle Beyond
Apr 18, 20261 min
US AI MedTech's Boardroom Blunder: A Pure Global Analysis
Apr 17, 20262 min
Pure Global: Brazil & Korea's MDSAP Domino Effect on MedTech Access
Apr 16, 20262 min
EU MedTech Cyber Crisis: Pure Global on Post-Attack Compliance
Apr 15, 20262 min
Pure Global: Europe's Widening AI MedTech Approval Maze
Apr 14, 20261 min
Pure Global: Brussels' AI MedTech Compliance Traps
Apr 13, 20261 min
Pure Global: EU IVD Chaos - Navigating the Last-Minute Squeeze
Apr 12, 20261 min
Washington's AI MedTech Rules: Pure Global on Hidden Traps
Apr 11, 20262 min
Pure Global: USA IVD's Seismic Shift on Lab-Developed Tests.
Apr 10, 20261 min
Pure Global: ASEAN's New MedTech Gateway in Malaysia & Thailand
Apr 9, 20261 min
Pure Global: USA's 510(k) Cybersecurity Ambush for MedTech Firms
Apr 8, 20262 min
Pure Global: US FDA's 510(k) Code Red on Cybersecurity
Apr 7, 20262 min
Europe's IVDR Deadline Chaos: A Pure Global Survival Guide
Apr 6, 20261 min
USA's MedTech Cyber Walls: Pure Global on FDA's Hidden Costs
Apr 5, 20261 min
USA's New FDA Platform: Pure Global on Hidden Post-Market Demands
Apr 4, 20261 min
Pure Global: US AI Diagnostics & The FDA's New Data Mandate
Apr 3, 20262 min
USA Ophthalmic Tech: Pure Global on the FDA's Classification Shakeup
Apr 2, 20262 min
USA AI MedTech: Pure Global on the FDA's Hidden Data Mandate
Apr 1, 20261 min
Pure Global: Malaysia's MedTech Handshake, ASEAN's New Shortcut
Mar 31, 20262 min
Pure Global: EU's MedTech Shortage & The New Supply Rules
Mar 30, 20261 min
Pure Global: Germany's AI Device Sudden Compliance Shock.
Mar 29, 20261 min
USA's QMSR Shockwave: Pure Global on Surviving FDA's New Audit Game
Mar 28, 20261 min
USA's FDA QMSR: Pure Global on Hidden Management Liability
Mar 27, 20262 min
Pure Global: USA MedTech Security & Why FDA's Honeymoon Is Over
Mar 26, 20261 min
USA 510(k) Cybersecurity: The 'Refuse to Accept' Trap | Pure Global
Mar 25, 20262 min
U.S. AI Medical Devices: Cracking the New Code | Pure Global
Mar 24, 20261 min
Pure Global: USA Robotic Surgery & FDA's Digital Deadlock.
Mar 23, 20262 min
US AI Diagnostics: Pure Global on FDA's Hidden Hurdles
Mar 22, 20262 min
Pure Global: EU MedTech's EUDAMED Deadline & Its Hidden Risks
Mar 21, 20261 min
USA's AI MedTech Shift: Pure Global on the FDA's Hidden Burden
Mar 20, 20261 min
Pure Global: EU IVDR Software's Silent Compliance Crisis
Mar 19, 20261 min