Matthew Diamond, MD, PhD’s Post

📣 Attention AI/ML developers, manufacturers and RA interested scrollers!!! New IMDRF document on "Good machine learning practice for medical device development - Guiding Principles" is now open for public consultation. We have been trying our very best to ensure that the most essential parts of creating a solid machine learning-enabled medical device are captured, but in case we missed anything, please let us know using the commenting template. Consultation closes on the 30th of August, so make sure to submit your comments before and enjoy the summer. 📅 🌞

Did you know? 🤔 In a document prepared by the TÜV AI.LAB, we find the abbreviation AIMDSW, which stands for Artificial Intelligence in Medical Device Software. Although AIMDSW is not yet commonly used, it’s worth remembering this abbreviation as the number of usage of AI in healthcare grows. Get to know more about AI Act in medical software development from our blog https://bit.ly/463iHJP #aisoftware #medai #healthcareai #medicalsoftware #samd

Chil Femtech Center introduces KETI 4.0, an AI Companion designed to assist in comprehending medical records. This groundbreaking tool enables users to input medical text, receiving simplified explanations in their preferred language. KETI does not substitute professional medical advice; it serves as a supplementary resource. Expert guidance remains paramount. https://lnkd.in/dKvTTDCD

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).

Meet Smarty, Scilife's Medical Device assistant powered by AI 🖥🧠 Smarty's data bank is stored with regulatory knowledge from the Medical Device industry to answer any queries you have. For instance, see what Smart has to say about: 🎯 What is the difference between 21 CFR 820 and ISO 13485? 🎯How should I conduct a management review according to ISO 13485? 🎯 What do I need to do if I want to develop a class II medical device? Try it out here: https://lnkd.in/dVft9_jN

The MHRA has added, to the Guidance on Software and Artificial Intelligence (AI) as a Medical Device ,the 5 guiding principles for the use of Predetermined Change Control Plans (PCCPs) to the AI section identified and endorsed by the MHRA, FDA and Health Canada. PCCPs provide a new method for managing rapid product changes often seen with Software and Artificial Intelligence products. These guiding principles will help to ensure alignment between these three jurisdictions on PCCPs and products utilising them. https://lnkd.in/eVc35AHB

Clinical decision support, medical devices, and AI: Attorney Bradley Merrill Thompson, RAC, discusses these topics, plus regulatory issues and more, in an interview with Xenophon Papademetris for Yale Online's Certificate Program on Medical Software and Medical AI. 🔗 Watch now: https://bit.ly/3vCyUaK #FDA #MedicalDevices #ArtificialIntelligence

🔍 EU AI Act <> MedTech Webinar Alert 🔍 With the EU AI Act officially adopted, MedTech companies building AI products must navigate new regulations. Join this insightful webinar on how the AI Act impacts the medical device industry. 🎙️ 📅 Date: May 30th 2024 🕒 Time: 16:00 - 17:00 Irish Time 📍 Register Here: https://lnkd.in/d4MUR4mf Expert speakers from industry, legal, and notified body TÜV SÜD will delve into: 📊 The gap between current compliance and the AI Act's requirements 🛠️ Real-world challenges manufacturers will face 🔎 The new combined conformity assessment procedure 📁 Practical implications focusing on data and documentation requirements #MedTech #AIAct #Webinar #MedicalDevices #Compliance #Regulations #AI #Innovation

🚨 Attention Medical Device Industry! 🚨 The FDA published its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines specific focus areas regarding the development and use of AI across the medical product lifecycle: https://lnkd.in/gPi8CcuX 💡 At NAMSA, we understand these challenges and are poised to be your partner in turning them into opportunities for growth and innovation. Our regulatory experts will guide you through the new challenges, ensuring precision and alignment with this new era of Artificial Intelligence. #NAMSAKnows

AI will, undoubtedly, change the way medical devices are developed. But organizations need to ensure they are engaging with reputable, knowledgeable, and trusting organizations to help with this journey. Thats where IBM Consulting can help you through the journey, no matter what AI or ML you utilize. "Regulators also highlighted the significance of pursuing human-centered design in product development, which accounts for the entire user experience. Effective transparency can also assist in controlling risks, the FDA said, by incorporating help from users in the detection of errors or investigations into declining performance."