AdvaMed Medical Imaging Standards
AdvaMed creates industry standards and white papers relevant to medical imaging technology, including X-Ray, CT, Ultrasound, MR, and molecular imaging modalities.
Racial and Ethnic Diversity in FDA Regulated Clinical Trials
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Phase III: Disparities in Access to Selected Advanced Medical Procedures in the Medicare Population
The final report of a three-part series investigates the prevalence of racial and ethnic disparities in the use of in the use of advanced interventions in the Medicare program.
Phase II: Literature Review: Racial Disparities in Use of Selected Medical Technologies
The second of a three-phase research series examines the difference in access to certain advanced interventions, including a range of surgical, medical and technological interventions.
Phase I: Disparities in Access to Advanced Medical Procedures in the Medicare Population
Racial and ethnic healthcare disparities in access to advanced interventions have persisted in the U.S. medical system. The first of a three-phase research series examines the difference in access to…
Automated Point-of-Care CAR T-Cell Fabrication & Democratization
MIDI describes recent advancements their team engineered in the biopharma fabrication space.
Managing Requirements – A Systems Approach to Medical Device Requirements for efficient and compliant design and development
Sunrise Labs outlines a systems approach to medical device requirements for efficient design and development..
Medicare Policy at the Crossroads: Addressing Artificial Intelligence and Software
Medicare beneficiaries stand to gain greatly from the ethical development and use of artificial intelligence (AI) and software solutions that improve the diagnosis and treatment of illness and disability, promote…
Medicare Coverage Processes: An Analysis of Procedural and Resource Concerns
This report focuses on coverage for devices and issues related to procedural delays, the lack of transparency in Medicare’s National Coverage Determination process, the use of Coverage with Evidence Development,…