Fact Sheet: EtO Sterilization Prevents Infection
Ethylene oxide sterilizes 20 billion medical devices in the United States each year. Sterilized equipment is critical to preventing serious, even life-threatening, infections in patients at the doctor and in the hospital every day.
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News / Coverage & Payment / Government & Legislative Affairs
AdvaMed Welcomes Bipartisan Senate Bill to Expedite Medicare Coverage of Breakthrough Medical Technologies, Diagnostic Tests
November 20, 2024
AdvaMed, the Medtech Association, today welcomed introduction in the U.S. Senate of bipartisan legislation to expedite Medicare coverage of FDA-“breakthrough”-designated medical technologies and diagnostic tests. The legislation, the Ensuring Patient Access to Critical Breakthrough Products Act, introduced by Sen. Todd Young (R-IN) and Sen. Alex Padilla (D-CA), is similar to H.R. 1691, which the U.S. House of Representatives Ways and Means Committee passed on a bipartisan basis in June.
Event / Regulatory Affairs
Medical Device Submissions Workshops – Premarket Approval (PMA)
8:30 am – 4:30 pm ET
February 6-7, 2025
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Event / Regulatory Affairs
Medical Device Submissions Workshops – Investigational Device Exemption (IDE)
8:30 am – 5:15 pm ET
February 5, 2025
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Event / China / Regulatory Affairs
China Regulatory Workshop
November 19, 2024 | 11:30 AM – 6:30 PM PT November 20, 2024 | 8:15 AM – 4:00 PM PT
Get the latest on new policy updates and guidance for the clinical evaluation of medical devices.
Blog / Government & Legislative Affairs / Medical Imaging
AdvaMed and Right Scan Right Time Host Successful Patient Fly-In Advocating for Increased Access to AI Cancer Screenings
August 19, 2024
In July, five patient leaders traveled to Capitol Hill to share their personal stories and speak to their lawmakers about the need to expand access to artificial intelligence technologies for medical imaging. The fly-in was held by Right Scan Right Time, a patient platform supported by AdvaMed Imaging.
Blog / Government & Legislative Affairs / Medical Imaging
AdvaMed Hosts Demo Day Showcasing Innovative AI Imaging Technologies for Congressional Staff
August 13, 2024
AdvaMed recently hosted an “AI Demo Day” on Capitol Hill, where a number of medical imaging innovators had the opportunity to showcase some of the latest artificial intelligence (AI) technologies to members of Congress and their staff.
Event / Regulatory Affairs
Medical Device Submissions Workshops – 510(k) and De Novo
8:30 am – 4:15 pm ET
February 3-4, 2025
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
News / Regulatory Affairs
Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening
July 31, 2024
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield™ blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease.