News | March 26, 2015

Edwards' CEO Addresses Senate Committee on Preserving, Strengthening U.S. Medical Device Innovation

Comments highlight improved collaboration, need to reduce regulatory and financial barriers

March 26, 2015 — Edwards Lifesciences Corp. announced that chairman and CEO Michael A. Mussallem served as an invited expert panelist on behalf of the Advanced Medical Technology Association (AdvaMed) at the United States Senate Health, Education, Labor and Pensions Committee hearing on "Continuing America's Leadership: Advancing Research and Development for Patients."

"As medical technology innovators, it's our passion and mission to continue developing better solutions to improve the lives of patients," said Mussallem.  "To maximize the impact of this work, it is imperative that we forge a path toward revitalizing the medical technology ecosystem in the United States. Continued innovation is vital to improving clinical outcomes, enhancing patients' quality of life and bringing increased value to the healthcare system."

Mussallem noted collaborative engagement and significant progress by the U.S. Food & Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) in better understanding and improving the predictability and approval timelines for future generations of medical devices.

He also addressed opportunities to further reduce barriers in regulatory approval and reimbursement, in order to help promote America's continued worldwide leadership in medical device development and also to support innovation. His comments focused on three primary areas:

  • the acceleration of FDA's vision to improve the regulatory process;
  • the need to strengthen the research and development infrastructure so it is second to none; and
  • continued encouragement of innovation by addressing issues throughout the entire ecosystem.

 

Mussallem also drew upon Edwards' experience with the Sapien transcatheter aortic heart valves to discuss the current regulatory environment in the United States.

For more information: www.edwards.com


Related Content

News | Heart Valve Technology

June 29, 2026 — Laplace Interventional recently announced that the U.S. Food and Drug Administration (FDA) has approved ...

Home July 02, 2026
Home
Feature | Heart Valve Technology | Kyle Hardner

Primary care providers (PCPs) stand on the front lines of diagnosing clinically significant valvular heart disease (VHD) ...

Home July 01, 2026
Home
News | Heart Valve Technology

June 29, 2026 — Konica Minolta, Inc. has announced that a research group has developed a simple and rapid technique for ...

Home June 29, 2026
Home
News | Heart Valve Technology

June 18, 2026 — Nyra Medical has been selected as the recipient of the 2026 Jon DeHaan Foundation Award for ...

Home June 19, 2026
Home
News | Heart Valve Technology

April 24, 2026 – A novel detection algorithm spotted moderate-to-severe aortic stenosis (AS) with a sensitivity of 90.5% ...

Home April 24, 2026
Home
News | Heart Valve Technology

April 21, 2026 — A new multicenter study published in The Annals of Thoracic Surgery finds that reoperative surgical ...

Home April 22, 2026
Home
News | Heart Valve Technology

Dec. 26, 2025 — Edwards Lifesciences has announced the company’s SAPIEN M3 mitral valve replacement system, a ...

Home December 24, 2025
Home
News | Heart Valve Technology

Nov. 17, 2025 — Royal Philips has introduced DeviceGuide, an AI-powered device tracking* solution that assists ...

Home November 17, 2025
Home
News | Heart Valve Technology | Cedars-Sinai Medical Center

Oct. 28, 2025 — People who underwent a minimally invasive procedure to have their heart’s aortic valve replaced had ...

Home October 29, 2025
Home
News | Heart Valve Technology

Aug. 28, 2025 — Medtronic plc has announced it received U.S. Food and Drug Administration (FDA) approval for the ...

Home August 29, 2025
Home
Subscribe Now