Third-Party Hardware Modification of Interventional X-Ray Equipment

The newAdvaMed® Imaging® technical white paper outlines concerns with third-party modification of interventional X-ray equipment, which can pose unforeseen risks for patients and providers. The white paper further calls for a complete technical assessment before using any third-party modification to mitigate potential harm.
This report provides our recommendations to regulators and other policy makers and stakeholders regarding third-party hardware modifications. Download the full white paper here.
Related Reading
News / AdvaMed Advancements / Artificial Intelligence (AI) / Coverage & Payment / Diabetes / Diagnostics / Digital Health / Global & Trade / Health Access / Investor Relations / Medical Imaging / Orthopedic / Regulatory Affairs / Tariffs / The MedTech Conference / Value-Based Collaborations
AdvaMed Concludes Record-Breaking MedTech Conference 2026
October 28, 2026
BOSTON—AdvaMed, the Medtech Association, concluded The MedTech Conference 2026, convening more than 4,470 attendees from 2,050 companies from 40 countries for the global medtech industry’s premier annual gathering.
News / Medical Imaging
Paradromics and Siemens Healthineers Launch Strategic Initiative to Build Advanced Imaging Foundation for the Future of Brain-Computer Interfaces
October 22, 2026
AUSTIN, Texas — October 19, 2026 — Paradromics Inc., a neurotechnology company developing high-data-rate brain-computer interfaces to restore and enhance human capabilities, today announced a collaboration with Siemens Healthineers to develop an advanced multimodal imaging platform designed to support the growing clinical use of implantable brain-computer interfaces (BCIs).
News / Medical Imaging / Regulatory Affairs / Standards
AdvaMed Names GE HealthCare’s John Jaeckle the 2026 Imaging Röntgen Award Recipient
October 16, 2026
WASHINGTON — AdvaMed, the Medtech Association, today announced that John Jaeckle, Chief Regulatory Affairs Strategist, at GE HealthCare, is the recipient of the 2026 AdvaMed Imaging Röntgen Award. The award recognizes Jaeckle’s more than 25 years of leadership in medical imaging regulation and standards development, including his work to advance computed tomography technology, performance and regulatory alignment in the United States and worldwide.
Blog / Legal / Medical Imaging
When is software not just software?
October 2, 2026
When is software not just software? That’s the question at the center of comments AdvaMed recently filed with the U.S. Copyright Office. At first glance, this may sound like a narrow dispute about medical device repair. In reality, it reflects a broader challenge facing a software-driven economy: how should the law treat software that is distinct from, but connected to, the products it supports?
News / Diagnostics / Medical Imaging / Regulatory Affairs
Cubresa Announces FDA 510(k) Clearance for the Cubresa BrainPET™ Scanner, Opening New Frontier in Clinical Brain Imaging
August 20, 2026
WINNIPEG, MANITOBA, CANADA, August 20, 2026 /EINPresswire.com/ — Cubresa Inc., a global leader in clinical and preclinical molecular imaging technologies, today announced that it has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Cubresa BrainPET™ scanner.
News / Medical Imaging
JAMA Surgery Publishes Landmark BrIMA Study Demonstrating Significant Improvement in Intraoperative Margin Assessment with Specimen PET-CT
June 26, 2026
GHENT, BELGIUM — XEOS, a medical technology company advancing intraoperative molecular imaging, today announced the publication of the BrIMA (Breast cancer Intraoperative Margin Assessment) study in JAMA Surgery, world’s leading peer reviewed surgical journals. The prospective, multicenter clinical trial demonstrated that the specimen images obtained with the AURA 10® PET-CT system significantly improved surgeons’ ability to identify and address positive margins during breast-conserving surgery, providing actionable information at the point where surgical decisions are made.
News / Medical Imaging / Small Business
Sonex Health Announces Data from Largest-ever U.S. Study Proving UltraGuideCTR™ Delivers Compelling Results for Carpal Tunnel Patients
June 15, 2026
EAGAN, Minn. – June 9, 2026 – Sonex Health, Inc. (Sonex Health) and The Institute of Advanced Ultrasound Guided Procedures today announced publication of six-month data demonstrating the safety and efficacy of ultrasound-guided carpal tunnel release (UGCTR) using UltraGuideCTR™. The study, published in the Journal of Hand Surgery Global Online, represents the largest prospective evaluation of UGCTR to date.
Blog / Coverage & Payment / Digital Health / Government & Legislative Affairs / Health Access / Medical Imaging
AdvaMed-Supported State Legislative Wins Advance Patient Access Across the U.S.
June 1, 2026
Millions of patients’ lives are improved every day because of advancements in medical technology. But too often, gaps in coverage and access prevent patients from benefiting from the safe, effective, and innovative technologies that can help detect disease earlier, improve treatment, and support better outcomes.
That is why AdvaMed’s 2026 Patients First Agenda focuses on supporting policies that put patients at the center of health care. Across the country, AdvaMed works alongside patient advocacy group partners to help address gaps in access and coverage for critical medical technologies and bring innovative care to patients and families when they need it most.