James Baillieu’s Post

Investigate of AI-as-medical-device Food and Drug Administration approvals from 1995–2023 to examine the contents, con- sistency, and transparency in FDA reporting of market-approved devices with a focus on bias.

FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Office of Combination Products recently published a joint discussion paper on artificial intelligence and medical products. Read our insights here. https://lnkd.in/ede_VVyB #AI #medicalproducts #devices

FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, and Office of Combination Products recently published a joint discussion paper on artificial intelligence and medical products. Read our insights here. https://lnkd.in/e_guKHhy #AI #medicalproducts #devices

In the USA, investigators are scrutinizing the healthcare industry’s use of #AI tools which are becoming very sophisticated and can match patients with particular drugs and devices. Not currently directed at AI use in #medicalinformation within pharmaceutical companies but its worth noting that AI use is starting to be evaluated to ensure that its not breaking any laws. Given the complex regulatory framework pharma work within, its worth acknowledging there may be restrictions put in place on how and when we can use AI in the future. https://lnkd.in/ekR8QqEv #digitalhealth #pharmaceutical #medicalaffairs #compliance

Discover the future of clinical trials in the medical device industry by embracing next-generation eClinical platforms. Our latest blog delves into the transformative power of #AI, unlocking unparalleled efficiency and innovation in medical device trials. Dive into the future now: https://hubs.ly/Q02fFZ7X0 Sign up for our upcoming webinar on EDC and Safety for Medical Devices Trials: https://hubs.ly/Q02fFxZq0 #CTMS #eTMF #EDC #RTSM #Safety #PV #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #Cloudbyz #ClinicalTrials #eClinicalPlatforms #MedicalDeviceTrials #AIInnovation

🔵 A company’s data asset is just as important as its therapeutic asset, especially when it comes to regulatory submission. Knowing what matters to regulators, and how you can generate the quality, compliant data they need is fundamental. See what regulatory bodies are looking for as the MedTech landscape constantly evolves, and why choosing the right technology is the first step toward a smooth medical device trial: https://bit.ly/49zgSVj #MedicalDevices #DataQuality #RealTimeData #ClinicalDataManagement #CDMS #EDC

FDA Publishes Artificial Intelligence Paper Today, 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. The multi-center effort from FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and the Office of Combination Products supports approaches to the safe, secure, ethical, and trustworthy development and use of AI. The paper reflects the agency’s commitment to prioritize collaboration, consistency, and mutual learning in this space. It also aims to promote responsible innovation, health equity, and patient-centricity by facilitating the secure, safe, ethical, and effective deployment and use of AI in medical products and in their development. #fda #artificialintelligence #machinelearning https://lnkd.in/gtw_hU8X

A new act in the EU with great impact, join this webinar to get the insight of the #Qserve experts

I wanted to let you know that I’ll be attending a webinar on the upcoming EU AI Act and its implications for the medical device and in vitro diagnostic (IVD) industry. It will cover important regulatory changes and compliance requirements. If you're interested in these topics, I recommend registering for the event. Let’s stay informed together!

FDA Publishes AI White Paper ◾ “Artificial Intelligence & Medical Products" discusses the use of AI across the product life cycle of “medical products.” The white paper describes the FDA's (U.S. Food and Drug Administration) intent to use a "risk-based" regulatory framework to evaluate AI in medical products. The four areas of FDA focus discussed are: ▪ Fostering Collaboration ▪ Advancing Innovation ▪ Harmonized Standards And Guidelines ▪ Supporting AI Research If this is your area of work or interest, the King & Spalding article can be found here: https://lnkd.in/eu4WrqPM #ai #artificialintelligence #aimedical