エピソード

  • Intuitive's Newest Robot: A Surgeon's Sense of Touch

    Intuitive's Newest Robot: A Surgeon's Sense of Touch
    2025/07/21
    This episode unpacks the landmark FDA clearance of Intuitive Surgical's da Vinci 5, the next generation in soft-tissue robotics. We explore its groundbreaking features, including Force Feedback technology that gives surgeons a sense of touch, a 10,000-fold increase in computing power, and enhanced 3D visualization. We also analyze its strategic importance in a competitive market and what it means for the future of surgery. Key Questions: • What is the most significant upgrade in Intuitive's da Vinci 5 system? • How does Force Feedback technology change the game for robotic surgery? • When did the FDA clear this new-generation device for the market? • Why is 10,000 times more computing power a critical feature? • How does the da Vinci 5 aim to improve OR workflow and efficiency? • What does this launch mean for competitors in the surgical robotics space? • How might this new technology impact patient outcomes? • What is Intuitive's strategy for rolling out the da Vinci 5? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants

    From Lab to Life: The Rise of Bioactive 3D-Printed Spinal Implants
    2025/07/20
    This episode delves into the revolutionary world of personalized 3D-printed spinal implants, highlighting Xenco Medical's TrabeculeX Continuum. We explore how its bioactive matrix eliminates the need for painful bone grafts, significantly reducing surgery time, and how its integrated recovery app is transforming postoperative care through remote monitoring and high patient engagement. Key Questions: • How can 3D printing revolutionize spinal implant surgery? • What are bioactive materials and how do they eliminate the need for bone grafting? • Can a medical device really reduce spinal surgery time by over 30 minutes? • How is digital health being integrated directly with surgical implants for better outcomes? • What does the future of postoperative recovery look like with remote monitoring apps? • Why was Xenco Medical named one of the world's most innovative companies in 2023? • How can high patient engagement with a recovery app transform the rehabilitation journey? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis

    The Remote Revolution: How At-Home Devices Are Solving the Physical Therapy Crisis
    2025/07/19
    This episode explores the rise of remote physical therapy devices like ROMTech's PortableConnect as a direct response to the significant shortage of physical therapists in the United States. We analyze the market drivers, patient benefits, and the critical market access hurdles, including payer reimbursement, that innovative MedTech companies face when introducing disruptive technologies. Key Questions: • What does the latest data from October 2024 reveal about the physical therapist shortage in the U.S.? • How does tele-rehabilitation technology aim to bridge the gap in patient care? • What is the ROMTech PortableConnect, and how does it function? • Can at-home devices truly deliver outcomes comparable to traditional, in-person physical therapy? • What are the reported cost savings for patients using remote therapy devices? • Why has prescription growth for these devices increased by 36% year-over-year? • What is the current stance of major insurance payers on reimbursing for this technology? • What regulatory and market access challenges do innovators in this space encounter? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • From Niche to Mainstream: The AI Revolution in Wearable Health Tech

    From Niche to Mainstream: The AI Revolution in Wearable Health Tech
    2025/07/19
    This episode explores the rapid expansion of AI-integrated wearables, focusing on how continuous glucose monitors (CGMs) are transitioning from clinical devices to mainstream wellness tools. We delve into the technological drivers, such as advanced sensors and on-device AI, and the market catalysts, including the 2024 Medicare coverage expansion, that are fueling a 25.53% CAGR in the wearable medtech market. • How are wearables evolving from simple trackers to predictive health monitors? • Why are continuous glucose monitors (CGMs) no longer just for people with diabetes? • What role does Artificial Intelligence (AI) play in real-time health analytics? • Which new over-the-counter devices from companies like Abbott and Dexcom are leading this trend in 2024? • How is the expansion of Medicare coverage accelerating the adoption of wearable medtech? • What does a 25.53% CAGR mean for the future of the wearable medical technology market? • Can these devices truly predict health events before they happen? • What do manufacturers need to know about the regulatory landscape for these new wellness devices? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • AI and the Heart: How 3D Modeling is Transforming Cardiac Diagnosis

    AI and the Heart: How 3D Modeling is Transforming Cardiac Diagnosis
    2025/07/18
    This episode delves into the revolutionary HeartFlow platform, an AI-powered diagnostic tool that creates personalized 3D models of the heart from CT scans. We explore how this technology is transforming the diagnosis of coronary artery disease by offering a non-invasive, highly accurate alternative to traditional methods, its key regulatory milestones with the FDA, and its rapid adoption in leading U.S. hospitals. Key Questions: • How can artificial intelligence create a 3D digital twin of a patient's heart? • What makes AI-powered diagnostics 95% accurate in identifying coronary artery disease? • How does this technology help clinicians distinguish between different types of plaque? • What were the key FDA clearances in 2014 and 2022 that expanded this platform's capabilities? • Why is a CMS reimbursement decision crucial for the market access of a new medical device? • How does providing anatomy, physiology, and plaque data in one test change patient care? • What has led 84% of top U.S. cardiac hospitals to adopt this technology? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • KIMES 2025: Your Gateway to South Korea's High-Tech Medical Device Market

    KIMES 2025: Your Gateway to South Korea's High-Tech Medical Device Market
    2025/07/17
    This episode explores South Korea's dynamic medical device market, providing a strategic preview of the upcoming Korea International Medical & Hospital Equipment Show (KIMES) in March 2025. We analyze the key growth trends, including the rapid adoption of AI in diagnostic imaging and the boom in portable and wearable health technologies. The discussion covers market drivers like the aging population and high-tech consumer base, while also outlining the regulatory landscape governed by the MFDS and opportunities for foreign manufacturers. • What makes South Korea a crucial market for MedTech expansion in Asia? • When and where is the next KIMES exhibition being held? • How is Artificial Intelligence revolutionizing medical imaging in Korea? • Why is there a surge in demand for portable and wearable medical devices? • What are the key drivers behind South Korea's multi-billion dollar medical device industry? • How does the Ministry of Food and Drug Safety (MFDS) impact market entry? • Where are the primary opportunities for foreign device manufacturers? • What strategies are essential for a successful launch in the Korean market? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • Guangzhou 2024: Inside China's 5G Smart Hospital Revolution

    Guangzhou 2024: Inside China's 5G Smart Hospital Revolution
    2025/07/16
    This episode dives into the upcoming Greater Bay Area International Medical Device Expo in Guangzhou, China, scheduled for September 23-25. We explore the event's core themes of "Smart Hospitals" and "5G Medical Ecology," detailing how these trends are shaping the future of MedTech in one of the world's most dynamic economic zones. This is a must-listen for professionals seeking to understand and penetrate the advanced Chinese healthcare market. Key Questions: • What makes China's Greater Bay Area a critical hub for MedTech innovation? • How is 5G technology transforming hospital infrastructure and patient care in the region? • What are the key opportunities at the Guangzhou expo from September 23rd to 25th? • Why is understanding the "Smart Hospital" concept, or 智慧医院, essential for market entry in China? • How can you connect with over 500 exhibitors and key regional stakeholders? • What specific digital health and connected device trends are dominating the GBA market? • Are you prepared to navigate the unique regulatory landscape of this powerful economic zone? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    3 分
  • Inside Riyadh's 2024 Global Health Exhibition: Your Gateway to Saudi MedTech

    Inside Riyadh's 2024 Global Health Exhibition: Your Gateway to Saudi MedTech
    2025/07/15
    This episode dives into the 2024 Global Health Exhibition in Riyadh, the largest healthcare event in Saudi Arabia. We explore how this event serves as a crucial gateway for medical device companies looking to capitalize on the Kingdom's Vision 2030, focusing on opportunities in government procurement, high-end equipment imports, and partnerships driven by massive national investment in healthcare transformation. • Why is the Global Health Exhibition a must-attend event for MedTech in 2024? • How is Saudi Arabia's Vision 2030 creating opportunities for medical device manufacturers? • What are the key dates and themes for this year's event in Riyadh? • Which technology sectors, like AI and digital health, are a major focus for investment? • How can companies connect with government procurement bodies and key investors? • What makes this year's exhibition the largest and most significant one yet? • What is the "Invest in Health" theme and what does it mean for market access? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.
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    2 分