『MedTech Global Insights』のカバーアート

MedTech Global Insights

MedTech Global Insights

著者： Ran Chen
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概要

 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.Copyright 2026 Ran Chen 生物科学 科学 経済学
エピソード
  • Pure Global: US LDT Rule, A Diagnostic World's Unseen Hurdles.

    Pure Global: US LDT Rule, A Diagnostic World's Unseen Hurdles.
    2026/02/13
    In a landmark decision, the U.S. FDA has finalized its rule to regulate Laboratory Developed Tests (LDTs) as medical devices, ending decades of enforcement discretion. This episode of MedTech Global Insights unpacks the immediate and long-term consequences of this industry-altering shift. We explore why the FDA made this move, what it means for clinical labs, and how it redraws the competitive map for diagnostic innovators. This isn't just a policy update; it's a fundamental change that will create new winners and losers across the MedTech landscape. We examine the tough road ahead for academic medical centers and startups, who now face the same stringent requirements as large commercial manufacturers. For patients and providers, this change promises safer, more reliable diagnostics, but at what potential cost to innovation and access to tests for rare conditions? **Key Takeaways:** * Why did the FDA end its decades-long hands-off approach to LDTs now? * What specific pre-market and post-market requirements will labs now face? * How will this regulatory shift impact patient access to cutting-edge diagnostics? * Which types of companies stand to win or lose in this new regulatory environment? * Could this rule stifle or ultimately improve the pace of diagnostic innovation? * What are the key deadlines in the FDA's multi-year phase-in plan? * How does this U.S. policy change affect international companies trying to enter the market? For more insights, contact us at info@pureglobal.com, visit https://pureglobal.com/, or access our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 分
  • Pure Global: US MedTech Cybersecurity's SBOM Reckoning

    Pure Global: US MedTech Cybersecurity's SBOM Reckoning
    2026/02/12
    A recent cybersecurity breach at a major US hospital, targeting connected infusion pumps, has sent shockwaves through the MedTech industry. The incident, which triggered a joint alert from the FDA and CISA, highlights the critical vulnerabilities that exist even in trusted medical devices and the immense pressure now on manufacturers. This episode of MedTech Global Insights unpacks the event and explores the new reality of cybersecurity compliance. We discuss the stringent new requirements from the FDA, including the mandatory Software Bill of Materials (SBOM), and how they align with the EU's MDR, forcing a complete lifecycle approach to device security. Imagine this scenario. a successful scaleup company finds its flagship diagnostic device, installed in hundreds of clinics, is suddenly vulnerable. A flaw was discovered not in their code, but in an open-source library their developers used years ago. Now, they face a regulatory nightmare, with market access at risk because they cannot prove to regulators they have a process to manage third-party software risks effectively. 本期干货: - Why is the latest US hospital breach a critical wake-up call for all IVD and MedTech firms globally? - What does the FDA's mandatory Software Bill of Materials (SBOM) *really* mean for your development team? - How do the EU MDR and FDA's cybersecurity guidances overlap, and where are the critical differences? - What are the most overlooked vulnerabilities hiding in legacy medical devices? - Is your post-market surveillance plan truly prepared for a zero-day exploit in third-party code? - How can you turn the burden of cybersecurity compliance into a competitive advantage and a mark of quality? - What crucial questions should you be asking your software suppliers and internal teams right now? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and free medical device database.
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    2 分
  • USA's LDT Shake-Up: Pure Global on Navigating FDA's New Rules

    USA's LDT Shake-Up: Pure Global on Navigating FDA's New Rules
    2026/02/11
    The U.S. FDA has finalized its rule to regulate Laboratory Developed Tests (LDTs) as medical devices, ending a long-standing policy of enforcement discretion. This episode of MedTech Global Insights breaks down one of the most significant regulatory shifts in the diagnostics industry in decades. We explore the immediate, practical consequences for clinical laboratories, from new compliance burdens to critical strategic decisions. We move beyond the headlines to examine what this means on the ground. For example, how does a university lab that developed a critical test for a rare pediatric cancer now cope with the prospect of a multi-million dollar FDA submission process? This rule is forcing labs to make tough choices that will directly impact patient access to innovative diagnostics. What You'll Learn: - Why is the FDA making this change after decades of a hands-off approach? - What are the key differences between former CLIA oversight and new medical device regulations? - How will the requirement for formal Quality Management Systems impact lab operations? - Could this rule create a gap in testing for rare diseases? - What are the first steps a lab should take to build a transition plan? - How might this regulatory shift trigger a new wave of mergers and acquisitions in the diagnostics space? - What are the potential pathways, like 510(k) or De Novo, for existing LDTs to gain approval? - Are there any exemptions for academic medical centers or low-volume tests? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and free medical device database.
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    2 分
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