We took time to reflect on another extraordinary year in the medtech industry and the tremendous strides we’ve made together. Our 2024 AdvaMed Annual Report highlights our key policy wins, pivotal moments, and meaningful progress we made toward longer-term policy goals. Together as an industry, we are shaping the future of health care, and 2024 moved us down that road! 

I hope you will read the entire report to get a better feel for the new policy landscape in which your company is operating, if only to share with us your feedback on our priorities on your behalf in 2025 and beyond. Here are just a few highlights from the report. In 2024, we: 

• Secured an expedited Medicare coverage pathway for breakthrough technologies, a longtime priority of AdvaMed’s that will help expedite access to FDA-cleared and FDA-designated “breakthrough” medical technologies through Medicare. We look forward to working to dramatically expand this pathway so that more patients can benefit from the groundbreaking work your companies are doing on their behalf. 

• Fully established AdvaMed’s Medical Imaging & Digital Health Tech Divisions, securing our organization’s representation for the first time in history of the entire medtech community. This strengthens our ability to represent you in the halls of Congress—and gives you greater opportunities to connect and grow your own organizations across any and all sectors of medtech. 

• Protected sterilization capacity for 20 billion medical devices sterilized annually in the U.S. with ethylene oxide, by ensuring EPA’s regulations continued to protect the communities surrounding these facilities while at the same time ensuring continued operations there. 

• Expanded CMS coverage for digital mental health technologies, a significant leap forward in making these essential tools accessible to more patients. 

• Achieving record attendance at The MedTech Conference, and our first one in an international location, with more than 4,350 attendees from 48 countries—showcasing the power of collaboration and innovation in action, and providing unparalleled opportunities for you and your companies to learn, grow, and network with likeminded companies, individuals, and even investors. 

This is only a snapshot of how, working together with you and your teams, we achieved meaningful progress on the policy environments in which your company operates. We lean into that work, so that you don’t have to—so that you can focus on what you do best—that is, transforming patients’ lives.  

Learn More About Medtech Wins Here. As you read, I hope you will reflect on how AdvaMed can better serve your company and the industry at large. Your insights and continued engagement will be key as we continue navigating an ever-evolving landscape. 

Together, we’re not just shaping the future of health care—we are transforming and saving countless lives. Thank you for the remarkable work you do, and thank you for being a part of AdvaMed, the Medtech Association. 

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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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Maria Artunduaga’s grandmother never smoked. However, like many members of her generation, she was exposed to second-hand cigarette smoke much of her life. When she developed chronic obstructive pulmonary disease (COPD), lung monitoring technologies were inadequate. Maria’s grandmother lived until age 90, but the last years of her life were exhausting and limiting. Going to mass once a week was all she could endure.

Maria, a Colombia native, arrived at a solution to help the millions of patients like her grandmother who are undertreated for a variety of serious respiratory conditions.

A few other paths came first.

An exceptional student, Maria went to college at age 16 and graduated at the top of her class from Colombia’s best medical school. In the United States, she conducted post-doctoral research in genetics at Harvard for four years.

Inspired by her family members, and motivated to help under-served patients, Maria decided to study plastic surgery to treat Colombian children born with cleft palates and other craniofacial malformations. Her younger sister has cerebral palsy and needed surgeries as a child for motor skills improvement. Colombia at the time had few, if any, surgeons focusing on these needs.

However, the path to plastic surgery went poorly. Studying at another U.S. university, Maria encountered tasteless jokes rooted in stereotypes about Colombia: living in the jungle, trafficking narcotics, guerrilla warfare, her accent and communication skills, her friendly personality, and more.  Colleagues questioned her credentials and her academic fitness for a top U.S. surgical program. She felt she didn’t belong.

After earning degrees in other fields, she found another path.

Scott May is executive director of the International Center for Professional Development, which runs the Scientist Mentoring & Diversity Program (SMDP) for MedTech, supported by sponsors including AdvaMed. The year-long mentoring program connects students from underrepresented groups with mentors in the medical technology industry. Scott’s team contacted Maria’s master’s degree program director at the University of California, Berkeley, to encourage her to apply. She did, and the program was revelatory.

“It was a very nice experience to get to be with people who have the same challenges as you do,” she said. “You’re Brown or you’re Black – we all have faced very similar issues, problems, challenges.”

In addition to the welcome introduction to peers, Maria realized medtech appealed to her love for “gadgets,” data, and tech.

The SMDP program also sharpened Maria’s characteristic determination. While attending a MedTech Innovator competition featuring companies with novel products, she realized all presenters were white men. She saw an opening.

“I’m going to show them there are more people who look and speak like me who can contribute significantly to the industry” if the men dominating medtech were just open-minded, she said.

The men of medtech were indeed welcoming and gave Maria ample advice as an entrepreneur.

Thinking of her grandmother, Maria created her company, Samay (“Samay” means “to breathe deeply” in the Quechua language, the second-most spoken language in the Andean region).

A medtech startup is hard, and Maria was solo. The hard work was worth it because she knew she was creating a good product.

“I need to be in love with the things that I’m working on,” she said.

Samay is developing a novel acoustic resonance patch for respiratory disease diagnosis, management, and intervention. The patient wears the patch like a continuous glucose monitor for diabetes. The device functions like miniature high-resolution headphones that also send signals and listen to them. The device can identify conditions such as COPD and asthma at low cost.

Samay earned numerous research grants. Maybe its most high-profile recognition yet, however, came at AdvaMed’s MedTech Conference in October in Toronto, when Samay won the $350,000 grand prize award from MedTech Innovator, the world’s largest accelerator of medical technology companies. AdvaMed hosts the MedTech Innovator competition and the SMDP scholars each year at The MedTech Conference, which convenes the next generation of entrepreneurs and aspiring leaders alongside the medtech industry’s leading companies, investors, and decision makers.

Samay earned the honor in a highly competitive process, the first Latin American company accepted to MedTech Innovator in its 12-year history.

Maria said she felt imposter syndrome at first, rising among 65 worthy competitors, with her company of 10 employees, most educated in Colombia, not at Harvard.

But the research grants continue to come in, and so does the data validating the Samay product. Additional grants and funding appear likely. The prospect of success is sinking in.

“It started with just me – a doctor with this crazy idea,” Maria said.

The name of the company’s device? “Sylvee,” after Maria’s beloved abuela, Sylvia.

Jennifer Brearey is executive director of AdvaMed Advance, an industry convener aimed at unlocking the power and potential of all talent and driving innovation in medical technology through achieving the best inclusion and diversity practices. Jennifer is also chief operating officer and chief financial officer of AdvaMed. 

Key Dates

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Our health care system moves at the speed of medtech innovation – and from my vantage point, that momentum is meteoric. We are living through a profound evolution in health care, fueled by the explosive growth of AI and digital technologies, driven by companies like yours. Which makes now the perfect time to join me and the global medtech community in Toronto—in just 19 days!—for The MedTech Conference. There is no better place to be as you seek to position yourself and your company heading into this era of innovation … 

Allow me to share why I’m so inspired by the overwhelming response to this year’s upcoming event: 

This is our first global event outside the United States, and we are seeing unprecedented early registration, with participation from over 44 countries. Some of our largest delegations come from Australia, Belgium, Brazil, Canada, Germany, India, Ireland, Japan, the Netherlands, and the UK, among others. 

Both the United States and Canada are seeing record registration, with top U.S. delegations so far from California, Massachusetts, and New York. Our attendee list is incredibly diverse, with hundreds of emerging companies, startups, top medtech CEOs and cofounders, along with large teams from leading companies. 

The Medtech Campus features a record number of companies participating as exhibitors, sponsors, company presenters, and speaking on a variety of stages.

For the first time, we’re introducing the “Tech in Motion Hub” in the Medtech Campus. This interactive area will feature cutting-edge technology, such as systems that deliver rapid, full-panel test results to patients in the palm of their hands; testing swabs that reduce barriers for women’s health screenings; and more innovations from companies like Baylis Medical Technologies, BD, Boston Scientific, FUJIFILM VisualSonics, Inc, GE HealthCare, Hologic, Siemens Healthineers and Solventum. I encourage everyone to visit the Hub from Tuesday through Thursday, where we’ll also have a few surprises in store.

This is your chance to connect with industry leaders, explore breakthrough technologies, and collaborate on the future of health care. Don’t miss the opportunity to be at the forefront of medtech innovation—register now and help shape the future of our industry.

I look forward to welcoming you to Toronto from October 15-17, where we’ll celebrate “Medtech in Motion” and explore new opportunities for growth, innovation, and partnership. 

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The following op-ed was published by The Minnesota Star Tribune on September 20, 2024:

The outcome of the 2024 presidential election stands to have a lasting impact on American health care. Questions surrounding artificial intelligence (AI) and its appropriate role in our society and economy are numerous and complex, and many of them remain unanswered.

As we grapple with AI’s place on our roads, in our classrooms and alongside us in the workplace, there’s one realm in which the careful, thoughtful development of artificial intelligence and machine learning is improving and saving lives today — and it’s only getting started.

Artificial intelligence is already playing a role in our health care and may already be playing a role in saving your life or that of someone you love.

Far from replacing your doctors, AI can assist them and make their job easier. The technology’s ability to consume and analyze millions of MRI scans, for example, and “learn” what a malignant tumor in your abdomen would look like, and then highlight it for your care team as they review the scans personally, is not only game-changing — it’s lifesaving.

Or take a revolutionary new colonoscopy software that uses AI to detect potential polyps or cancers in real time, providing immediate assistance to doctors during the procedure. Colon cancer is the fourth most common cancer, and the deadliest one for men under 50. It is hard to overstate the impact this AI-driven software and technologies like it will have on the early detection of cancer and diseases of all kinds.

Or consider the countless hours of paperwork saved by an AI system that fills out the standard surgical report — in the operating room, in real time, as your surgical team discusses the procedure aloud. Reducing administrative burden creates more time for the team to spend working directly with you, and more time to see and treat other patients in need.

Throughout the patient journey, from better screening and earlier diagnosis to more personalized treatment plans and improved patient monitoring, AI can give your care team more time for you and more accuracy in their diagnoses and treatments, and can help provide better outcomes for patients.

At the same time, AI can help reduce health care system costs through more efficient and streamlined hospital operations. Such savings are increasingly important, especially as other cost drivers in our health system — and to you as a patient — are on the rise.

A final but critical point is that the bar for medical device authorization is high and devices are governed by a rigorous regulatory system with regulators actively engaged in applying that framework to artificial intelligence-enabled devices. The FDA has already authorized nearly 900 AI- and/or machine-learning-enabled medical device applications; new technologies are submitted every day with the goal of improving patient care.

And yet, we fully appreciate some of the unease surrounding AI’s adoption, not only in health care but across our economy and society more broadly.

This initial reticence is all too common in the medical technology world.

Imagine, for example, the first patients suffering from heart disease to be told what they needed was a small, self-expanding mesh tube — what today we call a “stent” — surgically implanted in an artery to hold it open. No doubt many, if not all, reacted with skepticism, and possibly even abject fear. The idea may have even seemed ludicrous.

Fast-forward to today and it is a relatively easy, minimally invasive outpatient procedure so commonplace that it is almost taken for granted. The same can be said for countless groundbreaking procedures that were met initially with trepidation but that now are the standard of care.

Just as with the first stent implant, AI should of course be adopted with care and caution. But just as with stents, AI has the potential to grow into a remarkable everyday tool in the hands of skilled doctors and nurses who use it to improve and save patients’ lives.

The medical technology community’s vision is of a world where medical technology enables better outcomes for every patient, every time, everywhere. The digital revolution unfolding in front of us today, driven in no small part by artificial intelligence, will help us get there.

Pete Arduini is president and CEO of GE HealthCare, which has headquarters in Chicago. Scott Whitaker is president and CEO of AdvaMed, an association representing the medtech industry, with headquarters in Washington, D.C.

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First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

The Story

“Doing more cancer screening won’t reduce Black-white health disparities,” by Adewole Adamson, Vishal Patel, and G. Gilbert Welch

The Response

The op-ed unfairly and dangerously diminishes the value of cancer screening in reducing health disparities. As the writers acknowledge, numerous, complex factors contribute to poorer outcomes for Black patients than for white patients. Long-standing problems — like structural racism, poverty, lack of health insurance, and reduced care access — lead to poorer health and outcomes. Medtech innovators have forcefully advocated for Medicare, and other, policies to facilitate patient access to technologies, both established and emerging — including cancer screening — and are developing devices that are faster, more accurate, and more accessible than before. Cervical cancer screening kits for home use are in development. AI-enabled medtech devices are achieving more accurate diagnoses and helping clinicians find appropriate care pathways.

These devices have tremendous potential to reduce the number of tests needed for accurate diagnoses and to direct patients to the best care. Early detection can directly impact patient outcomes, treatment options, and financial burden. A patient whose cancer is detected early may have a better prognosis and may require less aggressive and/or less lengthy care. Longer care can be especially financially debilitating for under-resourced patients. Equal or higher rates of screening for Black patients relative to white patients is a positive development. It reflects years of dedicated advocacy toward getting patients what they need.

Of course, the work is far from over. For example, women with dense breast tissue need screening beyond mammograms, and access to supplemental screening is inadequate. Addressing health disparities in cancer diagnoses and care requires a comprehensive approach, and screening plays a vital role.

So rather than cast screening as the enemy, we should promote it alongside the necessary steps preceding and following it. Maybe screening gets an under-resourced patient in the door. If there’s a cancer diagnosis, the next step should be ensuring access to appropriate treatment, not devaluing the screening that led to the diagnosis.

The authors would have patients question the value of screening. Will that accomplish better health? Instead of dismissing cancer screening, which has been shown to work, those with a voice in health care debates should continue promoting equal access to all the resources that improve patient health.

— DeChane Dorsey and Deidre Washington, AdvaMed

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In the rapidly evolving medical technology sector, ethical business conduct is paramount to patient safety and advancing innovation. Over the years, standards for ethical business conduct have been raised, met, and exceeded thanks in no small part to the relentless drive of many in the medtech industry. The increasing complexity of global trade, however, underscores the need to look forward, strategize, and commit to continued hard work ahead. While the development and implementation of codes of ethics remain vital, these efforts can only go so far when some bad actors refuse to adhere to ethical standards. To tackle future challenges, even the world’s most ethical companies, including medtech companies, need bold action from governments to incentivize ethical business conduct.

AdvaMed is preparing to participate in the upcoming 2024 Business Ethics for APEC SMEs Forum and the 15th Meeting of the Inter-American Coalition for Business Ethics in the Medical Technology Sector from 16-18 September in Lima, Peru. These events will bring together hundreds of leading health care stakeholders, including the U.S. Department of Commerce and other Asia-Pacific Economic Cooperation (APEC) member economies, medtech associations and their member companies, patient and physician organizations, and others in health-related sectors to align on pivotal strategies for advancing business ethics. By focusing on collaborative solutions through collective action, these meetings aim to create a level playing field and ensure that the highest ethical standards are upheld across the industry. Key topics of discussion include incentivizing ethical business conduct in the public procurement process and continuing advancement of global harmonization of medtech industry codes of ethics.

AdvaMed welcomes the APEC Recommendations for Enterprise Integrity in Public Procurement and updates to the UNODC/OECD Resource Guide on State Measures for Strengthening Business Integrity, which include recommendations/guidance for enterprises/companies and economies/governments, including economy implementation of procurement incentives for enterprises that demonstrate ethical business conduct. The 11th APEC Business Ethics for SMEs Forum will utilize these resources, along with the APEC Kuala Lumpur Principles For Codes of Ethics in the Medical Technology Sector, to focus discussions on the practical application by enterprises and economies to enhance business integrity across the medtech sector, ensuring patient safety and building trust with the patients we serve.

• The APEC Recommendations provides that economies “[i]dentify enterprise integrity provisions within [their] public procurement system that incentivize ethical business conduct before, during, and/or after a public tender is awarded. One example of this provision can include demonstration by enterprises of adherence to a code of ethics, either as a qualification to participate or as an incentive in the tender process.”

• The UNODC/OECD Guide provides that “[t]he simplest form of [the public procurement] incentive is a requirement that companies meet certain minimum good practice standards as a condition for doing business with State agencies in charge of procurement. Mandatory programme requirements based on recognized sector-specific standards, such as codes of ethics, can be an effective way to strengthen business integrity practices, particularly in industries where a large portion of the marketplace consists of public purchasing or reimbursement. Multinational corporations frequently make available good practice guidance and training of key partners in their supply chains, including SMEs and other third-party intermediaries. Governments and industry associations also provide technical assistance to companies on the corporate integrity practices necessary for doing business with State agencies. This assistance takes the form of codes of ethics and guidance, training seminars, model content and other means.”

These resources provide a solid foundation for governments to implement incentives in public procurement for ethical business conduct, encouraging health care companies of all sizes to conduct business ethically. 

• The Inter-American Coalition for Business Ethics in the Medical Technology Sector has also benefited from the APEC and UNODC/OECD resources.  Objectives of the Coalition’s meeting include evaluating strategies for effective advocacy focused on the critical importance of maintaining rigorous ethical standards to ensure patient safety.

As we move beyond September, the collective efforts sparked through these initiatives will evolve with AdvaMed, its members, and global leaders strengthening the medtech sector through a continued commitment to ethical practices in procurement and codes of ethics, ensuring integrity and innovation remain intertwined.

Additional Background

Since 2010, AdvaMed has served as medtech industry lead for the APEC Business Ethics for SMEs Initiative, helping to extend high-standard codes of ethics to 31 medical technology associations across 19 economies in the APEC region. These associations collectively represent over 12,000 enterprises, of which over 10,000 are SMEs. The Business Ethics for SMEs initiative is the largest public- private partnership dedicated to promoting ethical business practices in health-related industries.

To learn more about AdvaMed’s Code of Ethics, click here.

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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.

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Medtech’s momentum is transforming health care, making this the perfect moment to join me and the global medtech community in Toronto in less than two months at The MedTech Conference. With advancements in technology, increased investment, and a global focus on innovation, medtech is now leading the charge in shaping the future of health care. 
 
Our industry is making rapid strides in AI, robotics, wearable devices, telemedicine, and personalized medicine—innovations that are enhancing patient care and making health care more accessible. As we stand at the forefront of these changes, there’s no better time to be part of this transformation. 

This is our first global event outside the United States, with registration at an all-time high and participation from over 40 countries. Sign in to see a sample list of our impressive attendees. 

The conference is your chance to connect with industry leaders, explore cutting-edge technologies, and collaborate on the future of health care. Don’t miss the opportunity to be at the heart of the medtech revolution—register now and help shape the future of our industry. 

I’m excited to share some great news: This year’s conference promises to be our most dynamic yet. Not only is our exhibit hall sold out and expanded, but we’ve also rebranded it as the Medtech Campus. This vibrant space will include an expanded Innovation Pavilion, a Tech in Motion Hub, a bustling Career Hub, and CEOs Unplugged. View the full listing of our education program. These enhancements reflect our commitment to advancing health care through technology and collaboration. 

I look forward to welcoming everyone to Toronto from October 15-17 as we celebrate “Medtech in Motion” and explore new avenues for growth, innovation, and partnership in our industry. 

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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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