David Salmon’s Post

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

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

As #AI #technology evolves, it’s reshaping the #medicaldevice industry📈 The FDA’s new Predetermined Change Control Plan (PCCP) is a key development for AI-enabled medical device software. In Bold Insight latest blog, Kyle Mullen, PhD explores the PCCP’s key components and offers practical tips for navigating this guidance. https://lnkd.in/gK4npGnn #healthcare #healthtech #GIANT2024

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."

📢 Join Fortrea for an upcoming webinar to explore the burgeoning field of software as a medical device (#SaMD), driven by advances in AI and machine learning. As SaMD becomes crucial for improving clinical outcomes and refining patient risk stratification, understanding the regulatory landscape is essential. The featured speakers will review the key components for successful SaMD regulatory submissions, including the latest global guidance and real-world examples of successful development. ➡️ Learn more + register here: https://buff.ly/4giAqBB #MedicalDevice #MedicalDeviceRegulation #LaboratoryTechnology #SoftwareAsAMedicalDevice #Regulatory

Please join us for a webinar on "The Impact of the EU AI Act on  Medical Devices and IVDs." The webinar will explore the impact of the AI Act on medical devices and IVDs, including an overview of the obligations that will apply to providers and deployers of relevant medical devices/IVDs, and detail on the timelines for compliance with the new rules.  

Are you considering pushing a 🙊LLM, 🙉LAM, 🙈LMM, or any large 💡 model through the FDA? This could save you trouble. We did a presub for a device that uses LLMs to detect contrast in the DICOM header info. How to FDA Approve LLMs. Step 1 Presubmission. https://hubs.li/Q02w3Qp70

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

This work was created to automate the annotation of medical images by pre-segmentation, I think it is time to continue in this line. https://lnkd.in/eCRRuqz3