Takeaways from the FDA's Guidance on using AI to support regulatory decision-making for drug and biological products (summary of the document) In this episode, we unpack the FDA's draft guidance on using artificial intelligence (AI) to support regulatory decision-making for drug and biological products. This guidance outlines a comprehensive framework for assessing the credibility of AI models, detailing essential steps like defining the context of use, evaluating model risk, and maintaining credibility across the product lifecycle. The document highlights the importance of transparency, data quality, and risk-based approaches to ensure that AI-driven insights meet the rigorous standards required for regulatory approval. Whether you're in the pharmaceutical or biotech sectors, this episode is a must-listen for understanding how AI can accelerate innovation while maintaining compliance with regulatory requirements. This AI-generated episode is designed to deliver key insights from complex industry updates in a fast, educational, and accessible format—helping you stay informed and ahead of the curve. Full guidance available here: https://www.fda.gov/media/184830/download This episode was crafted using AI, delivering the key takeaways from this important update in a concise, educational, and accessible format—perfect for staying informed on the go. Hosted by Ausha. See ausha.co/privacy-policy for more information.

Takeaways from the FDA's Guidance on AI-Enabled Device Software Functions (summary of the document) In this episode, we dive into the FDA's latest draft guidance on submitting information for medical devices powered by artificial intelligence (AI). This comprehensive guide provides non-binding recommendations on the documentation required for market authorization requests, covering crucial aspects such as device description, user interface, risk evaluation, data management, model validation, and cybersecurity. We explore how the FDA emphasizes transparency and a user-centered approach throughout the product lifecycle, ensuring safety and effectiveness in AI-driven medical devices. Additionally, we discuss the practical tools included in the guidance, such as documentation examples and model cards, designed to simplify and streamline the submission process. Whether you're in medtech, pharma, or curious about regulatory trends, this episode offers valuable insights into the evolving landscape of AI in healthcare. Full guidance available here: https://www.fda.gov/media/184856/download This episode was crafted using AI, delivering the key takeaways from this important update in a concise, educational, and accessible format—perfect for staying informed on the go. Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this episode, we’re joined by Julia Kern, co-CEO of SOMAREALITY, a Vienna-based startup pushing the boundaries of cognitive health with eye-tracking technology. Julia shares how SOMAREALITY is creating digital biomarkers that turn eye movements into real-time insights, paving the way for powerful new applications in healthcare and beyond. Topics Covered: From marketing to medicine: How eye-tracking evolved into a tool for cognitive health Decoding cognitive load and mental states through eye movements Inside SOMAREALITY’s biomarkers: Scientifically validated tools for understanding cognition Game-changing healthcare applications: Supporting surgical teams and assessing mental states VR and eye-tracking integration: Realistic simulations for cognitive research Beyond healthcare: Eye-tracking tech in automotive, aviation, and more Credits: Production: MedShake Studio Host: Anca Petre Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this episode, we’re joined by George Papagiannakis, co-founder and CEO of OramaVR, a Swiss deep tech startup focused on accelerating the world's transition to medical XR training. George is also a professor of computer graphics at the University of Crete, a researcher at FORTH, and a visiting professor at the University of Geneva and Stanford University. He shares his journey from computer science to medical training and discusses how virtual reality (VR) and artificial intelligence (AI) are revolutionizing the healthcare landscape. Topics Covered: George’s journey from computer science to medical training and the inception of OramaVR The integration of Web4, AI, and extended reality (XR) in healthcare The concept of digital twins for training, planning, navigation, rehabilitation, and therapy in medical procedures How XR and AI are being used to create customizable training and planning environments for healthcare professionals Differences in the adoption and innovation of medical XR technologies between Europe and the US Future trends in healthcare: the role of AI in creating the medical metaverse and personalized virtual environments for patient education Credits: Production: MedShake Studio Host: Anca Petre Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this episode, Anca Petre from MedRise Studio takes us on an exciting journey through the innovations she discovered at Dassault Systèmes’ 3D Experience Lab. From groundbreaking healthcare technologies to sustainability solutions, she shares her firsthand experience with some of the most incredible projects at this innovation incubator. Startups/project presented: - Damae Medical: A revolutionary skin cancer detection device that uses a tiny microscope to see beneath the skin's surface, providing non-invasive, real-time insights. - Inali Arms: Bionic arms controlled by brain signals, offering a game-changing solution for people with limb loss. - Grapheal: A smart wound care system with wearable patches that monitor wound health in real-time, sending data directly to your phone. - Lattice Medical: A bioresorbable tissue chamber that redefines breast reconstruction, promoting natural tissue growth after mastectomies. - Dot Lumen: AI-powered glasses that function like a guide dog, providing visually impaired individuals with enhanced mobility and independence. - Futura Gaia: Soil-based vertical farming with rotating beds, offering a sustainable way to grow food using up to 90% less water and no pesticides. - Atacama Biomaterials: An innovative solution replacing plastic with compostable and recyclable materials made from wood pulp. Credits: Production: MedShake Studio Host: Anca Petre Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this episode we're thrilled to welcome Natalia Sofia, a leading advocate in the Web3 space with a focus on empowering patients through decentralized health data management. Natalia shares her experience working on cutting-edge projects in digital health, including blockchain-based solutions for data governance, clinical trials, and patient identity systems. We explore how Web3 technologies are reshaping healthcare by giving patients control over their data, boosting personalized healthcare, and enabling secure, tamper-proof systems for data sharing. Key topics covered: How blockchain is revolutionizing clinical trials and data governance The rise of self-sovereign identity systems for health data security How decentralized platforms are accelerating research and drug discovery Real-world examples of frameworks like GDPR, FHIR, and eConsent in action If you're curious about the future of healthcare and how Web3 and blockchain will transform the way we manage health data, this episode is for you! Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this solo episode, Anca dives into the real-world potential of the metaverse in healthcare. Moving past the initial hype, Anca explores what the metaverse can actually deliver to enhance patient care, using data-driven insights to separate fact from fiction. Topics Covered: - Defining the metaverse and its role in healthcare - Improving access to healthcare through virtual clinics - Immersive experiences to reduce patient anxiety - The promise of digital twins and personalized care - Challenges with data privacy and security concerns - Regulatory hurdles and patient adoption barriers Credits: Production: MedShake Studio Host: Anca Petre Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this episode, host Anca revisits the 2024 Paris Olympics, a highly anticipated event that promised to integrate AI, blockchain, and Web3 technologies on an unprecedented scale. But did these innovations truly live up to the hype? Anca takes a closer look at what was promised versus what actually materialized, offering insights into the successes and shortfalls of these cutting-edge technologies. Topics Covered: - AI-powered security systems and their impact on crowd management - The role of digital twins in Olympic planning and logistics - Effectiveness of AI-generated personalized highlight reels - Blockchain-based ticketing: Hype or reality? - NFTs in fan engagement: Successes and challenges - AI tools for athlete health, injury management, and anti-doping efforts Credits: Production: MedShake Studio Host: Anca Petre Hosted by Ausha. See ausha.co/privacy-policy for more information.

In this episode, Anca Petre from Medrise Studio explores the intersection of fitness and cryptocurrency, diving into the world of "cryptofitness" where your workout efforts can translate into financial rewards. As people jump back into fitness routines post-Summer Olympics, the concept of earning while you burn is gaining traction. But what does the science say about it? Topics Covered: The rise of cryptofitness: How apps like Sweatcoin and Fitcoin reward exercise with cryptocurrency Exploring the integration of Extended Reality (XR) in fitness: Could "Pokémon Go meets Bitcoin" be the next big thing? Economic models of cryptofitness platforms: Are they sustainable or just modern pyramid schemes? Scientific insights on financial incentives and physical activity: What drives consistent behavior change? The role of social support in maintaining long-term fitness: Can virtual communities replicate real-life motivation? Credits: Production: MedShake Studio Host: Anca Petre Hosted by Ausha. See ausha.co/privacy-policy for more information.

Aujourd'hui, j’ai l'honneur d'accueillir Anne-Aurélie Epis de Fleurian, directrice de l'accès au marché et des affaires publiques de la startup Tilak Healthcare, spécialisée dans la création de thérapies digitales dans le domaine de l'ophtalmologie. Anne-Aurélie, pharmacienne de formation, a eu un parcours exceptionnel. Récemment, elle a été désignée parmi des personnalités qualifiées de la mission "Financement et régulation des produits de santé" demandée par la Première Ministre. Elle a également dirigé le département d'accès au marché d’IQVIA et du SNITEM. De plus, Anne-Aurélie a une passion pour le jeu sous toutes ses formes : elle a managé des équipes d’e-sport et adore les jeux de rôle grandeur nature. Dans cet épisode, elle explique comment Tilak Healthcare intègre la gamification dans ses solutions de thérapie digitale, visant notamment les patients âgés. Découvrez comment cette stratégie innovante améliore l'engagement et la rétention des patients, et explorez les perspectives futures de l'entreprise dans le domaine de la santé numérique. Hosted by Ausha. See ausha.co/privacy-policy for more information.