Check out GCMI's latest post featuring the Annual State of Medtech report. #medtech
AI’s potential and momentum in healthcare and medtech are massive. But the need for safety assurance remains paramount as regulators try to mitigate the risk of a technology that has many waypoints to achieve in the clinical care setting. https://lnkd.in/ecNt_9Zx
I highly recommend reading this insightful article by my colleague, Louise Maddison (Senior Consultant – Global Market Access), on the rapidly changing landscape for AI-enabled medical technologies in Europe. It covers the impact of new regulations, such as the EU AI Act, and evolving reimbursement frameworks. The article explores key markets such as France, Germany, and the UK, offering practical steps for navigating market access, from regulatory compliance to stakeholder engagement. Read the full article here 👉 https://lnkd.in/eDnXRi9R #AI #medtech #marketaccess #digitalhealth #healthcareinnovation #regulation #reimbursement
The landscape for AI-enabled medical technologies in Europe is rapidly changing, driven by new regulations and reimbursement frameworks. With the implementation of the EU AI Act and national-level pathways, navigating this evolving environment is crucial in bringing innovative healthcare solutions to market. In our latest article, Louise M. (Senior Consultant – Global Market Access, Mtech Access) dives into these developments, focusing on key markets such as France, Germany, and the UK. She discusses the critical steps for ensuring market access, from regulatory compliance to stakeholder engagement. Read the full article here 👉 https://lnkd.in/eDUQN3t3 #AI #medtech #marketaccess #digitalhealth #healthcareinnovation #regulation #reimbursement
I highly recommend reading this insightful article by my colleague, Louise Maddison (Senior Consultant – Global Market Access), on the rapidly changing landscape for AI-enabled medical technologies in Europe. It covers the impact of new regulations, such as the EU AI Act, and evolving reimbursement frameworks. The article explores key markets such as France, Germany, and the UK, offering practical steps for navigating market access, from regulatory compliance to stakeholder engagement. Read the full article here 👉 https://lnkd.in/e_cU-Abr #AI #medtech #marketaccess #digitalhealth #healthcareinnovation #regulation #reimbursement
Exciting development in establishing the safety of AI in healthcare. It will be interesting to see whether this approach is a safer, cheaper, robust alternative to current clinical trial methodologies, or if it supplements the existing evidence burden for manufacturers. Looking forward to more detail!! #AI #SafeAI #Healthcare #AIforgood #NHS
📢 Big news in the UK healthcare sector! The Medicines and Healthcare products Regulatory Agency is set to regulate #AI in medical devices, ensuring patient safety and innovation in #MedTech. This regulatory move will help set a standard for emerging AI-based solutions while providing clarity and guidance for manufacturers. Learn more about how this initiative aims to boost trust and transparency in the industry. 🔍🩺 #MedicalDevice #AIHealthcare Sam O'Leary Nathan Upton Nathan Read Alan Ling Jowell Grandison
The FDA’s recent focus on AI within medical products highlights a dynamic approach towards safety, innovation, and bias mitigation in healthcare. Key takeaways include a risk-based regulatory framework, forthcoming AI guidance documents, and a commitment to ensuring equity. For those in the healthcare and veteran communities, these developments promise to make significant impacts on patient care and medical product development. #HealthcareInnovation #FDA #ArtificialIntelligence #VeteransHealth
#AI was the No🥇 topic at #LTW, #HLTHEurope, and at all healthcare conferences this year. However, lack of clarity around regulatory requirements is one element that jeopardises market access and adoption. After publishing the '10 guiding principles for good machine learning practice' in 2021, the FDA, Health Canada and the UK MHRA collaborated to provide further details on transparency. This new document details the degree to which appropriate information about a machine learning-enabled #medicaldevice is considered as clearly communicated to relevant audiences, with guidance on where, when, and how to provide this information. Further #clarity and #collaboration between regulators is great news for medical devices leveraging AI. #machinelearning #marketaccess #innovation
CLEW's AI Models Clear FDA's Rigorous Review In a major milestone, CLEW Medical has received FDA 510(k) clearance for its second-generation AI/machine-learning models that predict patient deterioration. This follows CLEW's groundbreaking clearance as a class II medical device in 2021. CEO Paul Roscoe emphasizes CLEW's commitment to providing "the most sophisticated and accurate clinical predictions" by adhering to stringent regulatory processes for AI technology. The FDA clearance involved comprehensive safety and performance evaluations. A recent study in CHEST Journal found CLEW's predictions at least 5 times more accurate than leading telemedicine alerts. This achievement advances CLEW's intelligent clinical surveillance platform, enabling early identification of patient deterioration risk for improved outcomes. https://lnkd.in/gMS7Udrf Stay ahead of the curve by following Practical Patient Care on LinkedIn for more industry news and insights. You can also access our latest edition here: https://lnkd.in/guUBWkRE #PracticalPatientCare #AIPredictiveAnalytics #PatientDeteriorationPrediction #FDACleared #ClinicalSurveillance
🚀 #MedicalAI is changing the face of healthcare. But how do we ensure its benefits reach everyone? Discover the key to sustainable reimbursement models and the future of AI in medicine. 🤖💡 #LifeSciencesConsulting #ValueBasedHealthcare #AIConsultingTrends Read our latest article to learn how we can align stakeholder interests for the widespread adoption of medical AI. Let's shape a future where innovation meets accessibility. 🌐 👉 Click the link to learn more and join the conversation! #HealthcareInnovation #AIinHealthcare https://lnkd.in/eCbEMWDY
Launch Announcement: Welcome to 3Aware! On June 9, 2023, 3Aware was officially launched, marking a significant leap forward for the MedTech and HealthTech sectors. Born from a collaboration between Cook Medical and Health Cloud Ventures, 3Aware is set to transform post-market clinical follow-up (PMCF) and active surveillance, making medical devices safer, more effective, and more accessible while significantly reducing associated time, costs, and risks. With the global medical device industry facing a surgein compliance spending due to new regulations, 3Aware introduces aiSurveillance—a novel approach combining clinical and data science to connect longitudinal patient data, in a fit for purpose analytic platform. 🔗 Discover 3Aware and the future of #MedTech compliance: https://hubs.ly/Q02wYd7G0 #3Aware #MedTechInnovation #HealthTech #aiSurveillance #MedicalDevices #MedDeviceEU24 #GenerisEMD
