Episodi

  • UK AI Diagnostics: Pure Global on MHRA's Risky New Pathway.

    UK AI Diagnostics: Pure Global on MHRA's Risky New Pathway.
    Jan 22 2026
    This week on MedTech Global Insights, we dissect the UK MHRA's groundbreaking new accelerated approval pathway for AI-powered medical devices. This policy shift aims to make post-Brexit Britain a hub for digital health innovation, but what does it really mean for manufacturers on the ground? We explore the real-world implications through the lens of the first company to navigate this new process. Discover the potential pitfalls and strategic adjustments you must consider to capitalize on this opportunity without getting caught in unforeseen regulatory traps. A case in point is a startup with a revolutionary AI diagnostic tool. They saw the UK's new pathway as a golden ticket for rapid market entry, but they were unprepared for the vague requirements around real-world performance data and the intense scrutiny of their algorithm. Their dream of a quick launch is now bogged down by unexpected data demands and costly delays, highlighting a critical gap between policy and practice. Key Takeaways: - Is the MHRA's new AI pathway truly 'accelerated,' or just a different kind of bottleneck? - What are the top hidden data requirements that can derail your UK submission? - How does the UK's new framework compare to the FDA's De Novo and the EU's MDR for software devices? - Why might your existing clinical evidence not be sufficient for the MHRA's new standards? - What is the biggest cybersecurity risk you must address for a UK SaMD submission? - How can you leverage a single technical dossier for the UK, EU, and US markets simultaneously? - What are the post-market surveillance demands unique to this new UK pathway? Contact us at info@pureglobal.com or visit https://pureglobal.com/ or visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 min
  • EU's MDR Relief & Notified Body Rift: A Pure Global Brief

    EU's MDR Relief & Notified Body Rift: A Pure Global Brief
    Jan 21 2026
    The European Union's notoriously complex MDR and IVDR regulations have been a major challenge for the MedTech industry. Last week, the European Commission unveiled a proposal to simplify the rules, offering a glimmer of hope for manufacturers. However, the situation is complicated by a new position paper from the Notified Bodies (Team-NB), who are raising concerns about the proposed changes. This episode of MedTech Global Insights dives into this critical regulatory development. We explore the potential benefits of the Commission's proposal for companies trying to enter the EU market and dissect the crucial counterarguments from the Notified Bodies. This isn't just a regulatory update; it's a look into the dynamic and often conflicting forces shaping global market access. **Key Takeaways:** * What specific changes is the European Commission proposing for the MDR and IVDR? * Why are Notified Bodies expressing concerns about these proposed simplifications? * How could these changes impact the timeline and cost for getting a device to the EU market? * What are the potential risks for manufacturers if they misinterpret these evolving regulations? * For non-EU companies, does this proposal make the European market more or less attractive? * How should your company's regulatory strategy adapt to this period of uncertainty? * What does the tension between the Commission and Notified Bodies signal about the future of EU regulation? Contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 min
  • Pure Global: Europe's MedTech & The Post-Market Surprise

    Pure Global: Europe's MedTech & The Post-Market Surprise
    Jan 20 2026
    Many MedTech companies breathe a sigh of relief after achieving their European CE mark, believing the hardest part is over. But a recent guidance document from the EU's Medical Device Coordination Group (MDCG) on post-market surveillance is proving that the finish line has moved. This new interpretation demands a more dynamic and data-intensive approach to monitoring devices, catching many manufacturers off-guard. In this episode, we break down what this enhanced scrutiny really means for your business. We go beyond the regulatory jargon to reveal the hidden operational and financial burdens of these updated expectations, and discuss how proactive compliance is the only way to safeguard your hard-won market access in the EU. Imagine this: Your company's innovative cardiovascular device has been successful in the EU for two years. Suddenly, a routine audit flags your post-market data collection as non-compliant with the new MDCG guidance. You now have 90 days to implement a costly new patient follow-up study and overhaul your reporting system, or face the risk of having your CE certificate suspended right as you're planning your expansion. What You'll Learn: - What is the single biggest mistake companies make in their post-market surveillance plans? - How does the new MDCG guidance change the requirements for your Periodic Safety Update Report (PSUR)? - Why might your current clinical data be insufficient for the new Post-Market Clinical Follow-up (PMCF) standards? - What are the early warning signs that your PMS system is falling behind the new expectations? - How can you turn mandatory surveillance activities into a source of competitive advantage? - Is your designated Person Responsible for Regulatory Compliance (PRRC) truly prepared for these new demands? - What technology can help automate the intensified data collection and reporting? 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 min
  • USA LDT Crackdown: Pure Global on the New FDA Reality

    USA LDT Crackdown: Pure Global on the New FDA Reality
    Jan 19 2026
    The FDA has finalized its groundbreaking rule, ending its long-standing enforcement discretion for Laboratory Developed Tests (LDTs). This episode unpacks this monumental shift, explaining how thousands of clinical laboratories across the United States will now fall under full medical device regulations, fundamentally changing the diagnostics landscape. We break down the four-year, five-stage transition plan mandated by the FDA. From adverse event reporting to full premarket approval, we discuss the new requirements and what they mean for innovation, costs, and the very structure of the diagnostics industry. A leading university hospital in Boston has, for years, provided a life-saving proprietary oncology test for rare cancers. Now, they face a four-year deadline to validate this test under the FDA's stringent Quality System and premarket review process. This requires millions in new investment and a regulatory team they do not have, threatening to make their critical niche test financially unviable. This episode's key takeaways: 1. What does the LDT final rule mean for diagnostic tests currently on the market? 2. How can a laboratory begin building a compliant Quality Management System from scratch? 3. What are the key differences between the FDA's new oversight and the previous CLIA requirements? 4. Which specific types of LDTs are exempted from this rule, and could your test qualify? 5. What is the single biggest mistake a lab can make in the first year of this transition? 6. How will this rule impact the development timeline for new and innovative diagnostic tests? 7. What are the primary strategic options for labs: partner, sell, or invest in full compliance? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also visit https://pureglobal.ai/ for FREE AI tools and a free medical device database.
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    2 min
  • Pure Global: SF MedTech's Post-JPM Deal Shockwaves

    Pure Global: SF MedTech's Post-JPM Deal Shockwaves
    Jan 18 2026
    This week, we dissect the massive $3.7 billion acquisition of Axonics by Boston Scientific. This deal, announced during the landmark J.P. Morgan Healthcare Conference, signals a major shift in the MedTech M&A landscape and sets a new competitive dynamic in the sacral neuromodulation market. We explore the strategic thinking behind the acquisition, analyzing why Axonics became such an attractive target and what this means for Medtronic's long-held dominance. This episode provides critical insights for startups, investors, and established players on where the smart money is heading in 2024. **Case Study:** A fast-growing innovator, Axonics, took on an industry giant in a niche market and secured a multi-billion dollar exit. What were the key factors that made their technology and commercial strategy so irresistible to a strategic acquirer like Boston Scientific? **Key Takeaways:** - Why did Boston Scientific pay a $3.7 billion premium for Axonics? - Is this the beginning of the end for Medtronic's market dominance in sacral neuromodulation? - What does this deal signal for other MedTech startups looking for an exit in 2024? - Are high-growth, niche therapeutic areas the new battleground for M&A? - How did Axonics successfully challenge a market that was once a virtual monopoly? - Which clinical areas are likely to see the next wave of major acquisitions? - How can your company position itself to become an attractive acquisition target? For more insights, contact us at info@pureglobal.com or visit https://pureglobal.com/. For FREE AI tools and our comprehensive medical device database, visit https://pureglobal.ai/.
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    2 min
  • Pure Global: US Digital Health's TEMPO Pivot - Opportunity or Trap?

    Pure Global: US Digital Health's TEMPO Pivot - Opportunity or Trap?
    Jan 17 2026
    The U.S. FDA just launched the TEMPO pilot program, a groundbreaking "regulatory-light" pathway for digital health devices. This episode of MedTech Global Insights unpacks what this major shift means for manufacturers, how it ties regulatory approval directly to reimbursement, and why the game is changing for chronic disease management technologies. We look at the case of Ceribell, a company that recently secured three FDA approvals in rapid succession. Their platform-based approach is a masterclass in leveraging these new, agile regulatory frameworks. Learn how their strategy of iterative, multi-indication approvals could become the new standard for success in the competitive digital health space. Key Questions Answered: - What is the FDA's new TEMPO pilot program and who is it for? - How does a "regulatory-light" approach change the requirements for market approval? - Why is a platform-based technology strategy now more critical than ever? - What are the hidden data and cybersecurity challenges within the TEMPO program? - How does this new U.S. policy impact global regulatory strategy for digital health? - What can we learn from Ceribell’s recent string of FDA successes? - How will the TEMPO pilot affect reimbursement pathways for new technologies? Contact us at info@pureglobal.com, visit https://pureglobal.com/, or access free AI tools and a medical device database at https://pureglobal.ai/.
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    2 min
  • USA's Digital Health TEMPO Trap: A Pure Global Critical Update

    USA's Digital Health TEMPO Trap: A Pure Global Critical Update
    Jan 16 2026
    In this episode of MedTech Global Insights, we dissect two monumental shifts in the U.S. regulatory landscape happening right now. The FDA is rolling out its new TEMPO pilot program, offering a potential "regulatory light" pathway for digital health technologies. This could revolutionize market access for AI, machine learning, and chronic disease management devices. However, this opportunity is on a collision course with a major compliance deadline. In just a few weeks, the new, stricter Quality Management System Regulation (QMSR) becomes mandatory. We explore how companies can strategically leverage the promise of TEMPO without getting caught in the compliance trap of the QMSR, using recent successes from companies like Ceribell as a guide. Key Takeaways for this Episode: - What is the FDA's new TEMPO pilot, and could it be your ticket to the US market? - Why is the "regulatory light" approach for digital health not as simple as it sounds? - How can a platform technology strategy maximize the benefits of new FDA programs? - With the QMSR deadline weeks away, is your quality system truly inspection-ready? - How do you balance chasing new regulatory pathways while maintaining core compliance? - What are the critical documents you need prepared before applying to a program like TEMPO? - Could your supplier quality agreements put you at risk under the new QMSR? For more information, contact us at info@pureglobal.com or visit https://pureglobal.com/. You can also access our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 min
  • US Digital Health: Pure Global on the FDA's Deregulation Gamble

    US Digital Health: Pure Global on the FDA's Deregulation Gamble
    Jan 15 2026
    Last week, the US FDA announced a major shift in policy, easing regulations for low-risk digital health products and wearables. This move, revealed at CES 2026, aims to spur innovation by removing barriers for technologies that 'simply provide information' for general wellness. But this new freedom comes with a hidden challenge. The line between an unregulated wellness device and a regulated medical device is now more critical, and blurrier, than ever. This episode of MedTech Global Insights dissects the announcement, exploring the immense opportunities for innovators and the significant compliance risks for companies that misinterpret the FDA's new stance. Case in Point: Imagine your startup has a wellness app that tracks heart rate variability to help users manage stress. To add value, you push an update with a new alert for 'irregular patterns'. Have you just crossed the invisible line from a wellness product into a regulated medical device without realizing it? This episode explores that exact pain point and the potential consequences. Key Takeaways: - What does the FDA's phrase 'simply providing information' actually mean for product developers? - Where is the new dividing line between a consumer wellness wearable and a clinical diagnostic tool? - What are the biggest compliance traps for digital health startups under this new guidance? - How could this regulatory shift in the US impact global market strategies, including CE marking in Europe? - What key documentation should a company prepare to defend its 'non-medical device' classification? - How can software updates accidentally turn your unregulated product into a regulated one overnight? - What are the potential legal and financial penalties for misclassifying your device? For more insights and regulatory strategies, contact us at info@pureglobal.com or visit https://pureglobal.com/. Explore our FREE AI tools and medical device database at https://pureglobal.ai/.
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    2 min