For patients on Medicare, the majority of whom are over age 65, time matters. However, newly published research from the Stanford Byers Center for Biodesign shows that patients can wait up to 5 years after FDA authorization to access new medical technologies. Instead, a well-designed transitional coverage program could greatly accelerate patients’ access to care, while reducing the overall cost burden on our healthcare system. This program would also encourage innovation in areas of critically important unmet clinical needs. The Duke-Margolis Center for Health Policy has recommended the addition of several key elements to a transitional coverage pathway, highlighting the need for early engagement between stakeholders to inform and guide evidence development and appropriate use of novel technologies. Please join us to explore these findings and hear the perspectives of physicians, innovators and CMS stakeholders on this important initiative to advance patient care.
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In 2020, NAMSA hosted, “Transitioning from EUA to 510(k) Clearance for IVD Products: What to Expect?,” which focused on necessary regulatory, clinical and quality steps required to move from EUA to 510(k) approval. Two years later, we all have a stronger understanding of the expiration timeline for the Emergency Use Authorization (EUA) and a clearer picture of how to prepare for the upcoming changes. NAMSA invites you to attend this webinar where we will unpack the U.S. FDA draft guidance and discuss best practices for identifying gaps and maximizing your on-market product for a successful 510(k) submission, including an execution plan to achieve a quick and timely 510(k) approval. |
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Join JumpStart for the next episode of Founders Unfiltered featuring Afif Ghannoum, co-founder of BIOHM Health. Afif, a biotechnology attorney by training, co-founded BIOHM with his father Dr. Mahmoud Ghannoum, a global leader in medical mycology and Case Western Reserve University Professor. The father and son duo launched BIOHM in 2016 to help bring Dr. Ghannoum’s science to consumers, commercializing probiotics and microbiome testing kits to target fungi and bacteria in the digestive tract. JumpStart will talk to Afif about BIOHM’s recent funding round, the results of their groundbreaking clinical trials and his work commercializing healthcare innovation. |
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