Mauricio Rodriguez, P.Eng. M.Eng.’s Post

🚀 We are excited to share the latest industry report from the Medical Device Innovation Consortium (MDIC), dated September 2024: Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI) and Machine Learning (ML)-enabled Medical Devices. 🧠💡 This report outlines a proactive approach to managing iterative updates in AI/ML-enabled medical devices, ensuring they maintain safety and effectiveness post-market. With a structured PCCP, developers can now plan for software changes, communicate updates effectively, and ensure AI/ML systems continue learning while minimizing risks. This framework is crucial for advancing regulatory science, reducing product development costs, and bringing innovations to patients faster. A must-read for those in digital health, AI/ML and medical devices! #AI #MachineLearning #MedicalDevices #Innovation #Regulation #HealthcareTech #MDIC #PCCP https://lnkd.in/ebvTcXQP

Avicenna.AI Secures FDA Approval for Groundbreaking AI Diagnostic Solutions Avicenna.AI, the French medical imaging company, has received FDA approval for its AI-powered solutions, CINA-iPE and CINA-ASPECTS. These innovative tools leverage deep learning and machine learning technologies to automatically detect and prioritize life-threatening conditions, revolutionizing the field of diagnostic imaging. CINA-iPE is designed to detect incidental pulmonary embolisms during routine CT scans, a critical issue that often leads to delays and missed findings. CINA-ASPECTS, on the other hand, assesses stroke severity by automatically processing non-contrast CT scans and calculating the ASPECT score, improving physicians' reproducibility in this crucial assessment. These FDA-approved solutions mark a significant milestone for Avicenna.AI, as the company continues to push the boundaries of AI-powered diagnostics. By providing accurate and efficient tools, Avicenna.AI is poised to enhance patient care and transform the way healthcare professionals approach critical medical conditions. https://lnkd.in/eTm_aG_v Join Practical Patient Care for Daily Healthcare News Updates and Weekly Newsletter Subscription! #practicalpatientcare #Avicenna.AI #AIdiagnostics #FDAapproval #MedicalImaging

AI in Medical Devices: EU's New Regulations On July 12, 2024, Regulation 2024/1689 on artificial intelligence was published in the official journal of the European Union. Why should you care? → AI is transforming healthcare but needs guardrails. → These regulations ensure safer, smarter AI in medicine. → They demand transparency. How does your AI work? → They ensure reliability. Can your AI be trusted with lives? → They enforce accountability. Who’s responsible when AI makes decisions? This isn’t just about rules—it’s about trust and safety in AI systems that impact lives. What should your organization do? 1. Develop an AI governance strategy. Now. 2. Plan for compliance - time is running out. 3. Get clear on these detailed new requirements. 4. Embrace responsible AI practices to stay ahead globally. 5. Consider coaching your R&D and regulatory team on AI. So, if you’re in the healthcare space, you’ve got to keep up. The future of AI in medicine isn’t just about the tech—it’s about the trust we build around it.

Interesting to look at the stats on this #FDA site which lists all the #AI/ML enabled medical devices; https://lnkd.in/eAzPk6c7 Of the 882 devices authorized, 151 have a final decision date in the last year (8/1/23-3/31/24). Will be interesting to see what the next year's numbers are like, as clearly more devices are enabling AI/ML #medtech #software #sunriselabs.

AI in Healthcare: A Revolution in Diagnosis and Treatment AI is rapidly transforming the healthcare landscape, offering groundbreaking potential in medical research, diagnosis, and patient care. Here’s how: Enhanced Diagnosis: AI algorithms can analyze medical images (X-rays, MRIs, CT scans) with exceptional accuracy, often surpassing human capabilities. This leads to earlier and more precise diagnoses, improving patient outcomes. Personalized Treatment: AI-powered systems can analyze vast amounts of patient data, including genetic information and medical history, to develop highly personalized treatment plans. This tailored approach can optimize therapy effectiveness and minimize side effects. Drug Discovery: AI is accelerating drug discovery by simulating molecular interactions and predicting potential drug candidates. This can reduce development time and costs, bringing life-saving medications to market faster. Remote Monitoring: AI-enabled devices can monitor patients' vital signs and symptoms remotely, allowing for early detection of health issues and proactive interventions. This is particularly beneficial for those with chronic conditions or living in remote areas. Administrative Efficiency: AI can streamline administrative tasks such as medical coding, billing, and insurance claims processing, freeing up healthcare professionals to focus on patient care. As AI continues to evolve, its potential to revolutionize healthcare is immense. By leveraging AI's capabilities, we can improve patient outcomes, enhance healthcare efficiency, and drive innovation in medical research. #AIinHealthcare #MedicalAI #HealthcareInnovation #PrecisionMedicine #PatientCare

Wow. Allowing AI/ML devices to be cleared based on older, non-AI devices doesn’t seem to address the unique risks these technologies bring. If that 18.3% compromises our patients’ safety, it will be a serious problem. The FDA most definitely needs to step up and review their guidelines to avoid nightmares down the line. A reminder from my last post, it is crucial to clearly define the roles and responsibilities of all stakeholders in the development and deployment of AI/ML healthcare technologies to reduce the risk of AI-induced errors or harm. Thanks Rudolf Wagner for sharing this.

I feel the greatest challenges in integration of AI in medical imaging would be labelling and annotation of data which is very time consuming process. Also AI can be biased based on the training data provided.

View some of the key metrics from our recently published "AI in Medical Imaging World Market Analysis 2024" market intelligence report, that our Research Manager Amy Thompson has compiled for assessing the Medical Imaging AI landscape; it includes: 🔹 Market size for each clinical application as outlined in the report, alongside the projected 2028 market size ($m) 🔹 Comparison of standalone AI versus AV-bundled market share for each clinical application 🔹 Number of FDA regulatory approvals per clinical application in 2024 YTD Stay informed on the latest trends and insights shaping the future of AI in medical imaging. Our World Market Analysis 2024 report provides key insights and practical strategies to empower AI vendors in the medical imaging sector. It equips you with the tools to seize market opportunities and overcome barriers. It also includes strategic guidance, detailed market forecasts, and competitive profiles, giving you a distinct competitive edge in the industry. Connect with our report authors, Felix Beacher, PhD, and Amy Thompson, for a demonstration of our research capabilities. By doing so, you can gain a deeper understanding of the insights and strategies presented in our report, and how they can be applied to your specific business needs. Click the link below to request a brochure: https://lnkd.in/ejbybiHY. #AI #MedicalImaging #MarketAnalysis #FDAApprovals #marketintel

🌍 The European Commission has officially finalized the Artificial Intelligence Act, marking a pivotal moment for AI in medical devices. This milestone regulation sets the stage for a new era of innovation and safety in healthcare, ensuring that AI technologies in medical devices are held to the highest standards. As the regulatory landscape evolves, companies and innovators will need to adapt swiftly to stay compliant and harness the full potential of AI in the medical field. Learn more about how this will reshape the industry and what it means for the future of healthcare by reading the complete post ⤵️ https://lnkd.in/dmxSUJDc #RegASK #EuropeanUnion #RegAlerts #AI #ArtificialIntelligence #AIinMedicalDevices

🌟 Exciting advancements in healthcare AI! 🌍 The introduction of BiMediX2, a groundbreaking bilingual Bio-Medical LMM, is reshaping access to medical diagnostics. Here are key insights: 1️⃣ This innovative model is built on the Llama3.1 architecture and trained on a dataset of 1.6 million bilingual medical interactions, enhancing bilingual communication in clinical settings. 2️⃣ Achieving state-of-the-art performance, BiMediX2 improves Arabic evaluations by over 20% and exceeds many existing models, setting a new standard in multimodal medical applications. How is your organisation adapting to utilise AI in healthcare? Let’s discuss! #HealthcareAI #Innovation #Biomedicine