Axom’s Post

Guidance: Software and artificial intelligence (AI) as a medical device https://lnkd.in/gRQz-mdd Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

Medically-accurate models are useful tools in the medical industry – providing doctors, medical professionals, and patients a visual way to understand complex anatomy and how disease or injury can impact our bodies. Long a staple in doctors offices and medical institutions world-wide, these large, detailed, physical models have helped countless scores, but take up valuable space in a shrinking world. Hyper-specific, bulky, and quickly outdated, physical models, with all their drawbacks, have remained simply because of the educational value they provide.  But what if there was a better way? What if, by harnessing modern technologies, these models could be better – more interactive, more educational, more customized to the target audience? What if I tell you that through the power of Augmented Reality this revolution has already started?

Principles of Good Machine Learning Practices for Medical Device Development For my colleagues in the AI/ML space, IMDRF (International Medical Device Regulators Forum) has opened comments on their 10 principles of Good Machine Learning Practices for Medical Device Development. https://lnkd.in/e5xmYRx4

FDA has approved over 950+ AI-based Medical Devices! Great to see so many are ready to be deployed clinically. Most of them are in imaging, aiding diagnosis, and to some extent workflow. (Radiologists are among the most expensive and overworked specialties). Most of them are also approved via 510(k) which among other things, doesn't require clinical trials (but still requires proof of safety and effectiveness). So far, no GenAI or LLM devices. How many are *actually* in widespread clinical use? Hard to say. Improving workflows and operational efficiency is much more likely in the short term than big changes in clinical practice. But the fact that the FDA has ramped up the amount of approvals completed, and specifying which devices are AI-based is huge progress. We're years away from computers diagnosing disease without human oversight. If you'll excuse me, I've got to get a $2 Rx that was handled by a $150k pharmacist. 😉 Seriously though, drop your comments below on this development. https://lnkd.in/ggTxNbhu

AI is reshaping the medical device industry, but the use of this technology presents complex regulatory hurdles. Explore our article for key insights into how you can stay compliant, yet innovative in this new landscape. Essential reading for anyone in MedTech!👇 #medtech #innovation #AI #medicaldeviceregulation

We had a great time at the 14th Annual Medical Device & Diagnostic Labeling Conference in Chicago last week! Thank you to everyone who joined our featured session, “What’s Past is Prologue: The Evolution (And Future) of AI & Content Automation.” In case you missed it, our very own Division President, Medical Devices Marc Miller discussed ways to create competitive advantage by successfully anticipating innovation, including best practices for AI applications while navigating the regulatory environment in the EU. We look forward to continuing the conversation on AI and content automation in the future! #MedicalDevice #DiagnosticLabeling #ArtificialIntelligence

“Medical imaging analysis through AI has tremendous potential to assist healthcare professionals, and Grok seems to be making strides in that direction. Early stages like these are critical for feedback and improvement, paving the way for more accurate and reliable diagnostics in the future. It’s exciting to see technology move closer to enhancing healthcare accessibility and precision. Let’s contribute to refining this tool by sharing feedback to make it an invaluable asset in medical diagnostics!”

In recent years, the integration of Artificial Intelligence (AI) into medical devices has revolutionized healthcare, offering advanced diagnostics, personalized treatments, and improved patient outcomes. However, with these advancements come new challenges, particularly in navigating the complex landscape of medical device regulations. In this blog, we explore the evolving regulatory environment and provide insights for developers and stakeholders in the life sciences industry. Read Full Article: https://lnkd.in/e6Tq88Gi

Should the FDA regulate AI in medical devices differently? The Advanced Medical Technology Association and the American Hospital Association recently weighed in, arguing that the existing FDA framework for software as a medical device is sufficient for AI-powered devices. Those advocating for the existing framework believe it can adapt to address the unique challenges of AI, ensuring patient safety and innovation. However, others might argue that AI's complexity necessitates a more specific approach. What are your thoughts? Should the FDA adjust its approach to regulating AI in medical devices? Share your insights in the comments! https://lnkd.in/grG__vdt #AIinHealthcare #ArtificialIntelligence #PatrickGora #MedicalDevices #Healthcare #Regulation #FDA #SaMD

IMDRF publish Good Machine Learning Practice for Medical Device Development: Guiding Principles.