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.
AdvaMed Urges CMS to Issue Proposed TCET Rule This Year, Offers Direction on Achieving Success for Medicare Beneficiaries to Receive Latest Medical Technologies
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 Receives FDA Clearance for leva® Pelvic Health System as First-line Treatment for Chronic Fecal Incontinence
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).
AdvaMed Statement on the FDA’s Draft Commitment Letter on the Medical Device User Fee Amendments V Agreement
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…