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 [email protected] for tailored support.