Happy New Year!

In reflecting on our first full year with the MedTech Association, AdvaMed’s Imaging Division hit the ground running, laying a solid foundation for our advocacy efforts in the years ahead. We recruited more than 20 member companies to join AdvaMed, including five new AdvaMed Board members in our inaugural year, and stood up committees and sections for our members to collaborate on the most pressing issues for our industry.

The Imaging Division quickly positioned itself as a leader in advocating for expanded access to Artificial Intelligence (AI) and Machine Learning (ML)-enabled medical technologies, hosting a patient fly-in and AI Demo Day with Right Scan Right Time to showcase the real-world impact of these innovative tools.

This helped us lay the groundwork for legislation to be introduced that seeks to establish a payment pathway for AI-enabled medical devices. The Division also developed AI principles and engaged CMS on a payment pathway for AI-enabled medical devices in CMS’s CY 2025 proposed payment rule.

At CMS, we worked with the Agency to provide separate payment for radiopharmaceuticals from PET scans, which was a big win for patient access to care. After many years, we also successfully got CMS to cover CT colonography, another milestone win for patients.

We continued to closely collaborate with the Environmental Protection Agency’s (EPA) modality-by-modality approach to Energy Star for medical imaging, resulting in the final specification released in early 2025.

Meanwhile, the Imaging Division continued educating federal and state lawmakers on how so-called “right-to-repair” policies pose significant safety threats to patients when applied to medical devices. Together, we defeated a proposal to add a right to repair policy to the National Defense Authorization Act (NDAA) and continued our work in state capitals to ensure medical devices are exempted from any right to repair legislation considered.

In state legislatures across the country, AdvaMed’s Imaging Division led the charge to ensure more individuals can benefit from affordable early screenings and preventative care, sending over 20 letters in support of state legislation and seeing seven states pass supplemental breast cancer screening bills. Looking ahead, AdvaMed looks forward to continuing to champion state screening legislation to eliminate cost-sharing barriers for all. 

In its inaugural year representing the medical imaging industry, AdvaMed also achieved an important milestone: earning accreditation from the premier American National Standards Institute (ANSI) to develop industry standards for medical device innovation. ANSI accreditation signifies that AdvaMed’s standards development processes meet the highest national and international benchmarks for transparency, due process, and stakeholder engagement.

I’m proud of these accomplishments, which would not have been possible without our dedicated staff and the strong collaboration of our imaging member companies. As the medical technology sector continues to evolve in 2025 and beyond, AdvaMed remains committed to fostering and promoting innovation that takes patient care to the next level.

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Washington, D.C. – AdvaMed, the Medtech Association, commended the House of Representatives’ bipartisan Task Force on Artificial Intelligence for urging the Centers for Medicare & Medicaid Services (CMS) to develop a formalized payment pathway for AI-enabled medical devices. AI-enabled medical devices are FDA-cleared and produce clinical information to aid in patient diagnosis or treatment.

The Task Force highlights AI-enabled medical devices, stating, “Considering that AI tools streamline these practices and reduce time spent on services, current payment mechanisms cannot adequately reimburse these tools. Certainly, there will be no ‘one size fits all’ reimbursement policy for every AI technology, and developing appropriate payment mechanisms requires recognition of varying kinds of technology and clinical settings. For example, many AI technologies may fit into existing benefit categories or facility fees. Congress should continue to evaluate emerging technologies to ensure Medicare benefits adequately recognize appropriate AI-related medical technologies.”

The report went on to highlight the importance of data access, stating, “Policymakers could also develop or expand high-quality data access mechanisms that ensure the protection of patient data,” citing industry standards as a key path toward that goal. AdvaMed, which was recently accredited by the American National Standards Institute to develop industry standards for medical device innovation, looks forward to working alongside policymakers to enact policies that facilitate access to data and support standards development.

AdvaMed agrees with the Task Force suggestion that the Department of Commerce and other government agencies can learn more about AI risk mitigations through collaboration with the Food and Drug Administration (FDA) and the Department of Health & Human Services (HHS). AdvaMed stands ready to work with policymakers and the FDA to develop improved guidance for AI-enabled devices in the post-market space, as suggested in the report. 

Scott Whitaker, President and CEO of AdvaMed, said: “We thank these House lawmakers for their leadership and commitment to improving patient access to innovative medical devices. We look forward to continuing to work with CMS, patients, and policymakers to establish sensible, efficient Medicare coverage and reimbursement policies.”

Dr. Taha Kass-Hout, Global Chief Science and Technology Officer, GE HealthCare, and Chair of the AdvaMed Digital Health Tech Board of Directors, participated in an AI Task Force Panel examining Healthcare Applications. Each of the 15 AI Task Force Panels helped inform the report.

The Task Force’s report comes after continued advocacy in support of AI-enabled medical devices, including a bipartisan Senate letter and a patient sign-on letter sent to Congress earlier this year.

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AdvaMed creates industry standards and white papers relevant to medical technology, including X-Ray, CT, Ultrasound, MR, and molecular imaging modalities. AdvaMed is dedicated to ensuring standards the manufacturers’ needs as new technologies are developed in an ever-changing marketplace.  

AdvaMed is also an ANSI-accredited standards developer. ANSI accreditation signifies that AdvaMed’s standards development processes meet the highest national and international benchmarks for transparency, due process, and stakeholder engagement. 

Submit your interest in learning more information about AdvaMed’s Standards or contact standards@advamed.org to get involved.

Third-Party Hardware Modification of Interventional X-Ray Equipment: Issues to be Considered

Read AdvaMed’s recommendations to regulators and other policy makers and stakeholders regarding third-party hardware modifications (i.e., third-party modifications) that may impact device safety and effectiveness.

Read the full White Paper

Get Involved with AdvaMed

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The new AdvaMed 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.  

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WASHINGTON, D.C. – AdvaMed, the Medtech Association, recently published a technical white paper outlining concerns with third-party modification of interventional X-ray equipment, which can pose unforeseen risks for patients and providers.

While interventional X-ray equipment can help providers perform less-invasive clinical procedures, deployment of third-party hardware and modifications without verifying, testing, or validating compatibility to the original equipment manufacturer (OEM) and review by the U.S. Food and Drug Administration (FDA) for safety and effectiveness can introduce potential hazards and negatively impact device safety performance.

From the paper: “Unauthorized third-party modifications to interventional X-ray equipment represent a considerable risk to patient and operator safety. Adding a component, part, or material to a device could result in significant change to the original safety and performance specifications of the device.”

The white paper further calls for a complete technical assessment before using any third-party modification to mitigate potential harm. To ensure this, collaboration on this effort is needed among regulatory agencies, healthcare providers, and industry stakeholders in order to establish and enforce guidelines for the safe and effective use of any third-party medical imaging device modifications.

The white paper comes on the heels of AdvaMed receiving accreditation from the premier American National Standards Institute (ANSI) to develop industry standards for medical device innovation. As an ANSI-accredited organization, AdvaMed will begin by developing standards for medical imaging technologies, including applications important to all of medtech, such as cyber security and artificial intelligence.  

The full third-party hardware modification white paper is available below. 

Complete the form to download the Hardware Modification White Paper: 

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In letter to CMS: Gap in Coverage is an “Unacceptable Barrier” to Millions of Women with “Dense Breast Tissue”

Washington, D.C. –  AdvaMed, the Medtech Association, called on Medicare in a letter sent Friday to cover supplemental imaging for women with heterogeneously and extremely dense breast tissue, noting the life-saving value of the additional screening and the pressing health equity needs Medicare coverage of these critical services would address.   

“While supplemental imaging increases the effectiveness of detecting breast cancer in women with dense breast tissue, cost, availability, and insurance coverage limit its use,” Scott Whitaker, AdvaMed President and CEO, wrote to leaders at the Centers for Medicare & Medicaid Services. “As a result, beneficiaries may either forgo supplemental imaging or are surprised by bills, especially when those exams were recommended and ordered by their healthcare provider.”   

“Only 23% of Medicare beneficiaries are enrolled in a Medigap plan, leaving most without coverage for these cost-sharing gaps. This is an unacceptable barrier, especially given recently enacted FDA requirements that women be notified about their breast density and the inherent risk of dense breast tissue. AdvaMed urges CMS to cover imaging, in addition to a mammogram, for women with heterogeneously or extremely dense breast tissue,” the letter continues.  

Effective in September, the FDA requires mammographers to notify women when they have dense breast tissue. While traditional mammography is an important screening tool, it is less sensitive in women with dense breasts and more likely to miss cancer, especially at the critical early stages, than other imaging technologies such as ultrasounds, magnetic resonance imaging (MRI), or contrast-enhanced mammography.  

Breast cancer is the most diagnosed cancer among U.S. women. Seven out of ten cases of breast cancer are diagnosed in women aged 55 years and older. Additionally, nearly half of all women 40 and older who get mammograms are found to have dense breast tissue.  

Black women are often diagnosed with breast cancer at more advanced stages when treatment options are more limited, costly, and result in death rates 40 percent higher than white women. Black women may face worse disease progression in part because of their increased likelihood of having dense breast tissue.    

Recognizing these needs, a number of state legislatures have enacted legislation requiring insurers to cover supplemental breast cancer screening for women who need it. An additional number of states are considering such legislation. In Congress, a number of pending bills would require such coverage. Patient advocates have led this advocacy work, with strong support from AdvaMed and its member companies that innovate breast cancer screening technologies. AdvaMed thanked Senators Amy Klobuchar and Dr. Roger Marshall for their continued efforts to expand access to breast cancer screening by introducing the bipartisan Find it Early Act.  

Medicare coverage of supplemental imaging would close coverage gaps for women and save lives in states without laws covering additional imaging. Medicare coverage also would set an important precedent for state Medicaid programs and private health insurance plans, which often follow Medicare, as the nation’s largest insurance provider, in coverage decisions.  

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The MedTech Association Will Begin Developing Standards for Medical Imaging Devices, a “New Milestone” for AdvaMed

WASHINGTON – AdvaMed, the Medtech Association, announced today that it has received accreditation from the premier American National Standards Institute (ANSI) to develop industry standards for medical device innovation. As an ANSI-accredited organization, AdvaMed will begin by developing standards for medical imaging technologies, including applications important to all of medtech, such as cyber security and artificial intelligence.  

“Achieving ANSI accreditation is a testament to AdvaMed’s long history of advocating for and upholding the highest standards on behalf of the patients we serve. And this new milestone further demonstrates that AdvaMed is the place to be for medtech companies seeking not only to impact policy around the world but who want to ensure their companies and technologies are in the best possible position to succeed,” said Scott Whitaker, president and CEO of AdvaMed. “By adhering to ANSI’s procedures, we can more effectively advocate for policies that support industry advancement and improve patient outcomes.”

“Earning ANSI accreditation is an important milestone for AdvaMed in its inaugural year representing the medical imaging industry,” said Patrick Hope, executive director of AdvaMed’s Imaging Division. “AdvaMed’s ANSI-accredited standards will help ensure that the guidelines and specifications we develop reflect the consensus of imaging experts, aligning the practices and technologies of different manufacturers to foster uniformity and higher quality across the industry.” 

Official industry standards establish guidelines, specifications, and/or requirements for medical products, services, processes, or materials. These new AdvaMed-driven standards will:

• Help markets operate smoothly by establishing trust.
• Protect consumers by ensuring products are safe, effective, durable, and equitable.
• Enable “interoperability,” meaning technologies/devices from different manufacturers will be able to safely and effectively communicate with each other.
• Provide a common language to measure and evaluate performance.
• Help facilitate trade by providing a framework for achieving economies, efficiencies, and interoperability.
• Establish, measure, and assure quality and predictability.

ANSI accreditation signifies that AdvaMed’s standards development processes meet the highest national and international benchmarks for transparency, due process, and stakeholder engagement. ANSI accreditation confirms alignment with many governmental bodies that require ANSI accreditation to comply with licensing laws. Lastly, because ANSI is the official U.S. representative to the International Organization for Standardization (ISO), ANSI accreditation for medical devices ensures that U.S. standards align with international regulations, facilitating global market access and enhancing safety and efficacy across borders.

The accreditation process involved a comprehensive review of AdvaMed’s procedures for developing and maintaining industry standards, ensuring they are both rigorous and inclusive. AdvaMed has a strong history of engaging on U.S. and global standards policy issues. With ANSI’s endorsement, AdvaMed is better equipped to continue this collaboration with industry stakeholders, regulatory bodies, and other organizations to shape the future of medical technology. 

As the medical technology sector continues to evolve, AdvaMed remains committed to promoting best practices, fostering innovation, and ensuring that medical devices meet the highest standards of safety and efficacy. ANSI accreditation strengthens AdvaMed’s role as a leader in setting industry benchmarks and supporting its members by bringing groundbreaking technologies to market. In 2023, AdvaMed celebrated the 30^th anniversary of its Code of Ethics, which provides medical technology companies with guidance on ethical interactions and relationships with health care professionals, based on the cornerstone values of innovation, education, integrity, respect, responsibility, and transparency. 

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Years ago, my life was turned upside-down by an essential tremor, which caused my hand to shake so
severely that I had to leave my career as a nurse practitioner with the Department of Veterans Affairs.

My tremor meant I could not eat or socialize in public, engage in my passion for photography, or
complete simple repairs around my home that required a steady hand. Then, I received focused
ultrasound, a non-invasive therapy focusing beams of ultrasound energy deep into the body without
damaging surrounding tissue. Within four weeks of the procedure, my tremor was gone, and I was able
to return to my life.

While my treatment was a miracle cure, it didn’t come without a cost. The procedure wasn’t covered by
Medicare or private insurance, leaving me to use crowd-source funding to cover the procedure. Today,
many living with essential tremor, Parkinson’s disease, prostate cancer, or chronic pain are unable to
access this transformative technology.

That’s why I recently joined the Focused Ultrasound Foundation to meet with elected officials, including
Sen. Steve Daines and Rep. Ryan Zinke. I urged all of our federal representatives to support policies to
expand access to focused ultrasound, including H.R. 1691, a bill that would grant four years of
provisional Medicare coverage for medical devices deemed “breakthrough” by the Food and Drug
Administration.

This breakthrough procedure has opened my world, and I’m proud to advocate so others can access the
same focused ultrasound therapy that has made a difference in my life.

The post Letter to the Editor: Expand Access to Focused Ultrasound appeared first on AdvaMed.

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.

The patient constituents were welcomed into 16 lawmaker offices from 5 different states, where they discussed the potential for AI imaging technologies and advocated for increased access to these innovations. The advocates described how the lack of Medicare reimbursements for most AI medical imaging technologies prevents patients from benefitting from diagnostic AI. A few advocates even shared that they previously had misinterpreted scans, which may have been prevented if today’s AI technologies had been available to their care teams. Advocates urged their lawmakers to work with Medicare to promote patient access and establish a formalized payment pathway for these revolutionary technologies.

Through personal testimonies and bringing together the unique perspectives of cancer survivors and advocates, RSRT’s fly-in not only enabled legislators to hear real-life stories from their constituents but also helped formulate ongoing collaboration among policymakers and patients.

To help support access to innovative AI medical imaging technologies, click here.

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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.

Featuring imaging technologies from companies such as Siemens Healthineers and Philips, the event served to drive home the enormous potential that AI medical imaging has for the future of patient care and the need for the Centers for Medicare and Medicaid Services (CMS) to ensure patient access by implementing a payment pathway for AI-enabled medical technology.

AdvaMed’s AI Demo Day follows a letter sent by Senate AI Caucus Chairs, Senators Martin Heinrich (NM) and Mike Rounds (SD), along with Senators Marsha Blackburn (TN) and Todd Young (IN), urging CMS to develop a formal payment pathway for AI-enabled medical devices, linked here.

Only about 10 AI/ML medical device technologies are currently reimbursed by Medicare. With patients, providers, and lawmakers embracing AI-enabled medical devices, RSRT hopes that these cutting-edge, innovations will be accessible to all patients. This will only happen if federal policymakers establish Medicare reimbursement pathways for these technologies.

To read AdvaMed’s press release on AI Demo Day, click here.

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