CEO and surgeon Dr. Lishan Aklog speaks about the tremendous value of medical technology, the sharp disparities patients face, and the importance of policymaking to ease those disparities.
The Advanced Medical Technology Association (AdvaMed), the world’s largest trade association representing medical device manufacturers, urged the U.S. Centers for Medicare & Medicaid Services (CMS) to issue its proposed Transitional…
Renovia Inc., an AdvaMed member and developer of non-surgical, treatments for female pelvic floor disorders, announced the U.S. Food and Drug Administration (FDA) has cleared its leva® Pelvic Health System…
Join NAMSA and the FDA as they present a webinar on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA.
Congress is considering the latest agreement between the FDA and the industry to help fund agency consideration of medical devices with user fees.
AdvaMed member Cook Medical’s Zenith® Thoraco+ Endovascular System (Thoraco+) has received Breakthrough Device Designation from the US Food and Drug Administration (FDA).
AdvaMed welcomes the opportunity to testify before a key congressional committee on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA).
The Food and Drug Administration (FDA) has released its draft commitment letter on the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA), reflecting an agreement between the agency and the…