Kristin Davenport’s Post

“Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new challenges with the technology.” https://lnkd.in/gAKX3yqK

This video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI: https://lnkd.in/eF65H-Rt. 🎙 Our guest is Mr. Eric Henry, the Senior Quality Systems & Compliance Advisor at the law firm King & Spalding. He joined King & Spalding in 2018 after 30 years managing global technical and regulatory compliance organizations in various industries and in medical devices in particular over the last 22 years. 💡 We discuss the current and evolving state of medical AI regulation both in the United States and beyond. In particular we talk about the overall state of uncertainty in this area. In the EU, this is caused by the new EU AI Act and how it will be implemented (and how it relates to the Medical Device Regulation.) In the United States, we have a new administration that may change the priorities at the various agencies. We conclude with a discussion on issues related to healthcare AI tool development inside healthcare systems and the regulatory challenges that may arise there. Watch now: https://lnkd.in/gN9z2EKi Xenophon Papademetris | Yale Online | Yale School of Medicine #medicalsoftware #medicalai #airegulation

Excellent article on EU AI Act's impact on medical devices and life sciences and points on scope of inclusion/exclusion of symbolic fixed-algorithmic systems. Stay informed about the latest developments in the industry and how they may affect your work. #EUAIAct #medicaldevices #lifesciences

*NEW* Episode 34 of "Medical Compliance With Clarissa" is now live at https://lnkd.in/epCqC38V. Clarissa Benfield hosts Mike Lynch from Intertek's Medical Consulting team to talk #AI in med devices. We already see examples where Artificial Intelligence can save time, save money, and even save lives. The #FDA and other agencies now have guidelines and best practices published, with a roadmap for more formal guidance and requirements in the future. Listen to the full episode now. #MedicalDevices #Regulatory #MachineLearning

Euro Convergence: Experts concerned about incompatibilities between AI Act and MDR Regulatory News - 14 May 2024 - Ferdous Al-Faruque BERLIN – Experts are concerned that the recently adopted European Artificial Intelligence (AI) Act is in some ways incompatible with the Medical Device Regulation (MDR), in part due to conflicting terminology across the two documents.  During the 2024 RAPS Euro Convergence, a panel of experts discussed how medical devices under the AI Act, adopted by the EU in March, are treated compared to how they’re handled under MDR.

🧠💡 At 11 AM today, don’t miss our essential workshop: "Navigating AI Compliance in Medical Devices: Insights into AI Experts' Involvement in EU MDR 2017/745 Assessments" featuring Alberto Alvarez and Andrea Sanino from BSI Gain crucial insights into how AI experts are navigating compliance with the EU MDR 2017/745 regulations. Alberto Alvarez and Andrea Sanino will provide valuable perspectives on the challenges and solutions in assessing AI technologies for medical devices. #IH24 #SaveLivesWithAI #HealthcareAI #BSI

🔍 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

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

Avicenna.AI secures EU-MDR certification for five AI tools Avicenna.AI’s tools, which use AI to screen severe conditions from medical images, have been certified as Class IIb medical devices. The post Avicenna.AI secures EU-MDR certification for five AI tools appeared first on Medical Device Network.... https://lnkd.in/eNWvd8Zk #BioTech #science

When every moment counts in a medical emergency, #AI can help.SimWerx uses #IntelAI and #IntelGaudi accelerators to power Prediction Guard to help save lives by enhancing medical training and operational readiness. https://intel.ly/3SLD3Sm #ResponsibleAI #StartsWithIntel #LLM