Real-world evidence (RWE) is changing medical device approvals by providing efficient pathways that complement traditional clinical trials. What is the role of frameworks like the NEST Mark and SBARC in ensuring real-world data meets regulatory standards and supporting regulatory decision-making for innovative devices.
How can drug delivery devices manage competing priorities – reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.
Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a potential ban across the European Union. Such a ban would introduce a need for medical device manufacturers to identify and discontinue the sale of products containing PFAS, while also developing safe and effective alternatives. How will suppliers across the EU approach the impending shift away from these “forever chemicals”?
The MDIC Annual Public Forum 2024 kicked off this week with experts from the National Evaluation System for health Technology (NEST), the Centers for Medicare and Medicaid Services (CMS), and the FDA. Topics included the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem and how can we leverage emerging technologies to bring innovative and safer solutions to patients.
MedTech organizations need to focus on the human factor of change and achieve top-down alignment, buy-in, accountability, and clear communication along the way.
MEDICA 2024 and COMPAMED 2024 trade fairs in Düsseldorf, Germany attract more than 6,000 exhibitors from about 70 countries. These events are globally unique information and business platforms for the entire value chain of medical technology systems and products – including development and manufacturing. MEDICA and COMPAMED will take place from November 11 – 14, 2024.
Single-walled carbon nanotubes (SWCNTs) hold promise for biomedicine and nanoelectronics, yet the functionalization with single-stranded DNA (ssDNA) remains a challenge. In a new study, researchers from Korea functionalized SWCNTs using high-affinity ssDNA sequences identified through high-throughput selection. They demonstrated the effectivity and stability of these constructs using molecular dynamics simulations. Machine-learning models were used to accurately predict patterns that govern ssDNA-SWCNT binding affinity. These findings provide valuable insights into the interactions between ssDNA and SWCNTs.
CitiusTech Senior VP and Market Head, Healthcare Providers, John Squeo, shares five game-changing shifts that will redefine the future of US healthcare and unlock a more streamlined, accessible and patient-centric system.
An analysis from the Life Sciences legal team at Hogan Lovells.
Medical Device Original Equipment Manufacturers (OEMs) are increasingly seeking sophisticated thermal solutions to improve medical device performance. How does the transition from traditional heaters to advanced, layered heater technologies impacts device design?