FUJIFILM Healthcare Americas Corporation’s Post

It’s been almost 20 years since the FDA approved its first AI/ML-enabled medical device – and wow, things have evolved since then. Explore some of the latest advancements in our blog: https://bit.ly/3QL4PwI #ArtificialIntelligence #MachineLearning #MedicalDevices

Did you know you might be able to leverage Computational Modeling and Simulations as part of your #FDA premarket submission. There has already been quite a few devices who have leveraged this technique as part of their validation and received clearance. We delve into what those possibilities are below. #medicaldevices #regulatory #computationalmodeling #premarketsubmission #radiology #samd #digitalhealth #artificialintelligence #machinelearning #simulation

Abhineet Johri from Siemens Healthineers is providing insights into the development lifecycle of an AI Software as a Medical Device (SaMD). He shares an overview of the AI SaMD development process, from conception to deployment and discusses the unique challenges associated with developing AI-driven medical devices, including regulatory and technical hurdles, highlighting best practices to ensure that AI SaMDs meet high standards of safety, efficacy, and compliance. #ConnectedCombinedProducts #MPP2024 #DigitalTransformation

Meet your new FDA AI assistant - Tryout FDA Copilot today #AIInHealthcare #FDAUpdates #FDAAIcopilot #HealthcareInnovation

🚀 Save the date for the next Regulatory Bits on 24 June from 12.00 - 12.30. Join us and explore the innovative use of AI to facilitate and improve the medical device certification process under the Medical Device Regulation (MDR). 🔎 AI4MDR: Leveraging AI for Regulatory Excellence 📅 24 June I 12.00 - 12.30 Registration: https://bit.ly/3WD48tS Dietmar Schaffarczyk Ivo Schauwecker Jörg Goldhahn Anja Finkel Isabella De Nitti Wernli #regulatorybits #dTIP #AI4MDR #medicaldeviceregulation #regulatory #ETHZürich

As #AI in medical devices evolves, it’s crucial to keep them safe and effective. This report offers helpful guidance for medical device stakeholders on planning updates and staying ahead of regulatory requirements. Definitely worth a read for anyone in the field!

AI Regulations: A Priority for Medical Device Manufacturers Understanding and adapting to the regulatory landscape surrounding AI is not just beneficial, but crucial for future success. https://lnkd.in/e5MPEARJ

AI Regulations: A Priority for Medical Device Manufacturers Understanding and adapting to the regulatory landscape surrounding AI is not just beneficial, but crucial for future success. https://lnkd.in/e5MPEARJ

⚠️ 🚧Legislative coherence is needed to provide legal certainty for #medtech: Medical Devices and Diagnostics that contain #ai need to comply now with the new horizontal 🇪🇺 #AIAct. That comes in addition to the existing sector specific 🇪🇺#MDR and #IVDR which already includes specific requirements for digital MDs. Manufacturers need to comply with both laws. That raises pragmatic questions on how to do it without duplication and delay. Future #guidance will hopefully bring swift clarification 🍀. #innovation #digitalhealth

🚨 Time is running out to book your place on our upcoming event: Regulatory Perspective: Digital Health and AI. Our speakers will be covering these critical topics: - AI in Medical Devices and In-Vitro Diagnostic Devices: Regulatory Landscape and Notified Body Expectations – AI Act + MDR/IVDR (Marco Caproni) - The Role of Data in Healthcare: Impacts of the New Regulatory Scheme on Digital MedTech Companies (Elena Lucano) - Navigating Regulatory Hurdles for AI-ML in Medical Devices: Opportunities and Challenges in the EU Market (Flavio Angei, RAC) Spaces are extremely limited and you do need to book in advance to attend. Sign up now > https://lnkd.in/dEnw8Jwd #medtech #regulatoryaffairs #rapsswitzerlandchapter #digitalhealth #ai