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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Event / Regulatory Affairs
FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
April 13, 2026
10:00 AM – 11:00 AM
Join Hogan Lovells in this webinar will examine FDA for-cause inspections as they relate to medical device manufacturers.
News / Business Development / Government & Legislative Affairs / Small Business
AdvaMed Welcomes House Passage of Legislation Restoring Programs That Jumpstart Early-stage Medtech Innovation
March 17, 2026
WASHINGTON—AdvaMed, the Medtech Association, today applauded House of Representatives passage of S. 3971, the Small Business Innovation and Economic Security Act, legislation reauthorizing the federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. House passage follows Senate passage earlier this month, bringing the restoration of these initiatives one step closer to completion.
Resource / Digital Health / Government & Legislative Affairs
AdvaMed® 2025 Membership Has Its Privileges: Advocacy Wins for Medtech Members
March 3, 2026
AdvaMed® 2025 Membership Has Its Privileges highlights major legislative and regulatory wins delivering millions in savings and new revenue for members.
Resource / Government & Legislative Affairs
Scott Whitaker Op-Ed: Medicare must keep pace with FDA-authorized breakthrough medical technologies
February 27, 2026
Medicare breakthrough medical technologies face delays between FDA authorization and coverage decisions, slowing patient access to innovation.
Event / Emerging Policy Response Resources / Global & Trade / Government & Legislative Affairs / Supply Chain / Tariffs
Navigating the ACCESS & TEMPO Models: A Direct Dialogue with CMMI & FDA Leaders
On Demand
Watch AdvaMed’s® exclusive member-only webinar featuring a direct dialogue with CMS Innovation Center leadership on the newly released ACCESS & TEMPO Model. Attendees will gain critical insights into model performance metrics, payment pathways, and opportunities for the MedTech industry.
Resource / Artificial Intelligence (AI) / Coverage & Payment / Digital Health / Regulatory Affairs
AdvaMed® Comment Letter to ASTP/ONC: Accelerating AI Adoption in Clinical Care
February 24, 2026
AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.
News / Artificial Intelligence (AI) / Regulatory Affairs
i-GENTIC AI Launches Context-Aware MedTech Agents to Strengthen FDA 510(k) Submission Consistency
February 23, 2026
PALO ALTO, Calif., Feb. 11, 2026 i-GENTIC AI today announced a new suite of context-aware, multilingual MedTech agents designed to help medical device manufacturers improve the quality and consistency of FDA 510(k) submissions. Preparing a 510(k) often takes months, yet many submissions require additional information requests or are rejected due to inconsistencies across documents, evidence, and claims, creating delays and added costs for manufacturers.
Event / Emerging Policy Response Resources / Global & Trade / Government & Legislative Affairs / Supply Chain / Tariffs
The Supreme Court Struck Down IEEPA Tariffs – What Medtech Needs To Know
Now On Demand
The U.S. Supreme Court recently marked a significant shift in the tariff landscape, learn what that means for your organization.