Aetion’s Post

ICYMI - Aetion has achieved its first FDA device clearance and label change using real-world data (RWD), in collaboration with Intuitive, FDA, and NEST. The revised labeling for Intuitive’s da Vinci X and Xi systems is based on RWD showing similar long-term survival rates for robotic-assisted and non-robotic radical prostatectomy, showcasing the power of RWD in advancing cancer treatment and regulatory science. Learn more here: https://hubs.li/Q02FggSc0 #Innovation #Healthcare #RoboticSurgery #CancerTreatment #FDA #RWD

Empowering Healthcare: Global Efforts for Transparent AI in Medical Devices The FDA, Health Canada | Santé Canada, and the U.K. Medicines and Healthcare products Regulatory Agency are collaborating to ensure transparency in #AI-powered medical devices. Building on their 2021 set of best practices, the latest guidelines emphasize transparency for all stakeholders, including health professionals, patients, administrators, payors, and governing bodies. It is our stance that the adoption of AI technologies in health care could lead to great improvements in efficiency, patient care and medical research, accelerating the discoveries that lead to new cures. And as this update outlines specifically for machine learning-enabled medical devices, transparency is a good practice for all applications of AI. Learn more: https://hubs.li/Q02DYWCn0

Swift insights are crucial for healthcare’s most critical decisions. With Aetion Discover, we bring together our top-tier analytics capabilities with a user-centric interface to serve up insights that are quick, clear, and reliable. Schedule a demo here: https://hubs.li/Q02DYCGp0

Now live on the Aetion Evidence Hub, discover how a recent study with Aetion, EMA, and the TREAT-NMD network using #RWD is shaping the future of Spinal Muscular Atrophy research. Find out how registry data is advancing treatment options for rare diseases like SMA. #RareDisease #RealWorldData #SMAResearch. Learn more here: https://hubs.li/Q02DpQqj0

Regulators are placing a greater emphasis on understanding how medical products work in historically underrepresented populations. One such approach involves Congress mandating that manufacturers create Diversity Action Plans for products seeking approvals. A new research article from Friends of Cancer Research notes that oncology product manufacturers “now incorporate diversity considerations into their trial planning processes by using epidemiologic data sources to assess disease burden and inform site selection”: https://hubs.li/Q02DgJn10

See for yourself why Aetion® Substantiate is the standard-setting #RWE application of choice used by global biopharma organizations, regulators, payers, and health technology assessment bodies—schedule a demo with one of our experts today: https://hubs.li/Q02D4QsN0

ICYMI—Aetion's Ann Madsen (VP, Science) sat down with The Evidence Base® to discuss the poster—‘An Emulation of the KEYNOTE-189 Trial Using Electronic Health Records’—recently presented at #ISPORAnnual. Here, you'll find out that while the initial pilot didn't match the #RCT results, it laid the groundwork for future emulations and highlighted the potential of #RWE to complement traditional trials. Full article here: https://hubs.li/Q02D4NMT0

In a recent blog authored by Nicholaas Honig (Head of Regulatory and Sr. Counsel at Aetion), learn how the need for transparent and rigorous #RWE has never been greater and how Aetion is working to ensure validity in RWE studies with tools like #SPACE and #SPIFD2. Find the full blog now on the Aetion Evidence Hub: https://hubs.li/Q02CJ6yQ0

With Aetion® Generate, harness the power of generative AI to detect and resolve re-identification risks. Schedule a demo today to find out how: https://hubs.li/Q02C2QHv0