Washington, D.C. –   AdvaMed, the Medtech Association, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Robert F. Kennedy, Jr. to serve as Secretary of the U.S. Department of Health and Human Services:

“We congratulate Secretary Kennedy on his confirmation to lead the U.S. Department of Health and Human Services. In his confirmation hearings, Secretary Kennedy emphasized his aim to fight the chronic disease epidemic and help Americans avoid prolonged treatments and hospitalizations. He expressed his hope to achieve the President’s goal of improving the health of every American. Our industry shares that goal. It is our entire mission. And we stand ready to help Secretary Kennedy to establish the policy landscape necessary for our medical technology innovators to achieve this mutually shared goal through the very innovation that has made our country the global leader in medtech.

“Secretary Kennedy will oversee the FDA, which is critical to maintaining our position as the most innovative country in the world with respect to the medical technologies that save countless lives daily. HHS also oversees CMS, which manages Medicare, the nation’s largest health care insurer. Medicare coverage and reimbursement decisions determine whether its beneficiaries will have access to procedures driven by life-changing, lifesaving medtech. These critical decisions impact not only the 67 million people covered by Medicare but every American.

“The medical technology industry is the backbone of our health care system. Our innovations in the hands of doctors and nurses in every care setting are essential to ensuring that America gets back on track to healthier and longer lives. We look forward to sharing with Secretary Kennedy and his team how medtech brings tremendous value to patients and the U.S. health care system.”

For more on how medtech has saved and improved lives, from adding five years to life expectancy to cutting fatalities from heart disease and stroke by 49 percent to reducing the number of days spent in the hospital, please see our medtech industry facts.

The post AdvaMed Congratulates HHS Secretary Robert F. Kennedy, Jr. appeared first on AdvaMed.

HAYWARD, Calif. — BUSINESS WIRE/ —  RefleXion Medical, a theranostic oncology company, today announced the scheduled installation of its RefleXion® X1 platform with SCINTIX® biology-guided radiotherapy at Beverly Hills Cancer Center (BHCC), the first freestanding cancer center (FSCC) that has installed the RefleXion X1.

Read more.

The post RefleXion Expands Access to SCINTIX Therapy with First Freestanding Cancer Center appeared first on AdvaMed.

Washington, D.C. –   On the Medtech POV podcast, AdvaMed President and CEO Scott Whitaker sat down with recently retired U.S. Rep. Brad Wenstrup of Ohio, discussing lessons learned from the COVID-19 pandemic, illogical budgetary scoring of health care procedures, and Wenstrup’s life-saving triage of U.S. House of Representatives Majority Leader Steve Scalise after a shooting. 

Wenstrup is a podiatric surgeon, a colonel in the U.S. Army Reserve, and an Iraqi War veteran. He served as the U.S. representative for Ohio’s 2^nd congressional district from 2013 to early 2025, with service on the Ways and Means and Intelligence committees. He chaired the Select Subcommittee on the Coronavirus Pandemic and urged listeners to read the subcommittee’s final report recommendations. 

“They’re nonpartisan. They just make sense for America,” Wenstrup said. “Those are the lessons learned from along the way. I’m not trying to cast as much aspersion on those that were trying to do the right thing, but let’s do better next time from the lessons learned.” 

Wenstrup was the lead Republican co-sponsor of the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act, H.R. 1691 in the last Congress, to give Medicare beneficiaries faster access to safe, effective, FDA-designated breakthrough medical devices. The Ways and Means Committee approved the bill, and AdvaMed will seek re-introduction and enactment in the new Congress. 

Wenstrup advocates for common sense in the congressional scoring and insurance coverage, including Medicare, of medical procedures and treatments. Current consideration downplays the cost savings of preventive measures and cures that might be costly at the outset but provide considerable cost savings over a patient’s life and even more importantly, restore the patient to wellness, Wenstrup said. 

“We’ve got to be patient centric,” he said. “There is a return on investment. If you have some new technology or innovation, that even if it’s a device for the rest of your life, but it allows you to go back and live your life and go to work and raise your family, that’s a pretty good return on investment.”  

Wenstrup details his experience treating Scalise moments after Scalise’s shooting on a baseball field in 2017.  

“Steve is such an amazing guy,” Wenstrup said. “Tremendous courage through all that, never complained, multiple surgeries and everything else, and he just keeps on going. He always says, oh, Brad, you’re my hero, and I’m like, no, you are mine, because I don’t know how many people that have had the strength and courage that he has.” 

To hear the full conversation, download the Medtech POV podcast on Spotify,  Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed’s website for more information on the podcast and past guests. 

The post Medtech POV Podcast: Rep. Brad Wenstrup on COVID-19 Lessons, Common Sense in Health Care, and Treating Shooting Victim Scalise appeared first on AdvaMed.

Washington, D.C. –  AdvaMed, the Medtech Association, today released the following statement from President and CEO Scott Whitaker following the imposition of tariffs on products from Canada, Mexico, and China: 

“We share President Trump’s goal to protect public health, as well as his deep concern for the terrible impact drugs have on too many Americans and on our health care system. This is also why we are concerned about tariffs on medical products from Canada, Mexico, and China. 

“We have shared with the Administration our concerns about the potential impact tariffs could have on the medical technology supply chain that American patients depend on for their care. In light of that risk, an exemption was provided for most medical devices during President Trump’s first term with respect to the tariffs on China, and we are advocating for a similar approach this time. We will closely monitor for any effects the tariffs may have on this critical supply chain and share that information with the Administration.” 

Whitaker continued: “Our industry is heavily regulated: FDA decides what products can be put on the market, and then Medicaid, Medicare, and the VA largely determine the reimbursement for procedures using medtech products. This means tariffs impact American companies similarly to an excise tax, which would lead to less R&D/innovation, layoffs, higher prices for the above-mentioned payors and patients, or all of the above. Additionally, moving manufacturing from one facility to a different or new facility requires FDA approval, which makes it difficult in the short term to adjust production to the U.S. 

“The increased costs posed by tariffs, and their functioning essentially as an excise tax in practice, could resurrect the climate of concern the medical device excise tax created for nearly a decade.

“During the President’s first term with respect to the tariffs on China, a carve-out was provided for much of the medtech sector, given the risks to the U.S. hospital supply chain. We maintain that the potential supply chain disruption and its downstream effects on patients remain a risk, should tariffs be implemented. Shortages of critical medical technologies are a real concern in our initial modeling.  

“Tariffs could hold back the innovation potential of the U.S. medtech industry. R&D spending would likely be the first and most direct casualty, threatening America’s medtech innovation leadership. And increased tariffs may even have the unintended consequence of boosting the competitiveness of medtech industries of other nations.    

“We hope that these critical facts resonate with the Administration, and we will continue to make our case on behalf of the patients our companies serve.”

The post AdvaMed Seeks Medical Technology Exemption from All Tariffs appeared first on AdvaMed.

Washington, D.C. – Today, AdvaMed, the Medtech Association, released its “Patients First Agenda,” a series of state-level policies aimed at improving lives and patient outcomes through increasing access to medical technology, accurate diagnostic testing, and safe and effective treatments. Each policy is a key priority for patient advocacy organizations or professional medical societies, further underscoring the initiatives’ importance in improving patient lives and outcomes.

“AdvaMed is proud to be a strong partner with each of these organizations and to engage in building support for these policies in states around the country,” said Scott Whitaker, AdvaMed President and CEO. “Access to medical technology is critical to improving the well-being of patients, and we will advocate for the policies we developed with patient groups to meet these needs. We look forward to working with our partners and state policymakers to secure adoption of these patient-focused proposals.”

Partners shared their thanks for AdvaMed’s support of these policies:

American Cancer Society Cancer Action Network

“AdvaMed has long been a strong advocate for policies increasing patient access to innovative medical technologies at both the federal and state levels. We’re looking forward to continuing to work with them on ensuring that patients around the country have access to necessary biomarker testing that can improve their care and outcomes.”

Alzheimer’s Association

“As we enter a new era of Alzheimer’s treatment and care, early detection and diagnosis has become even more critical for those impacted by this devastating disease. To meet this moment, the Alzheimer’s Association is proud to partner with organizations like AdvaMed to advance state policies that will ensure access to innovative biomarker testing.”

American College of Emergency Physicians

“Testing for opioids in emergency settings can help save lives by ensuring the right treatment is provided to patients at the right time. We’re pleased to be working with AdvaMed on policies improving access for patients in these often-fast-moving situations.”

LUNGevity

“Out-of-pocket cost should not be a barrier for patients with lung cancer and other diseases to access necessary care. That’s why we’re pleased that AdvaMed is supporting state-based legislation that would remove cost-sharing for supplemental cancer imaging and diagnostics, as well as legislation that would increase coverage of biomarker testing.”

Fight Colorectal Cancer

“The last thing on patients’ minds when a physician recommends further testing for colorectal cancer should be ‘can I afford it?’ We are grateful for the support of partners like AdvaMed in our efforts to advance legislation to reduce barriers and increase access to life-saving colorectal cancer screening.”

Epilepsy Foundation of America

“Seizure detection devices can help enhance safety, improve quality of life, and enable timely medical response. The Epilepsy Foundation of America supports state-level legislation that would provide Medicaid coverage of the device and its ongoing costs to increase equitable access to emerging, innovative technologies that help families. The Epilepsy Foundation is grateful for AdvaMed’s support of this impactful and forward-looking legislation.”

Brem Foundation to Defeat Breast Cancer

“Too often, women are foregoing crucial breast cancer imaging or diagnostic tests because of prohibitive cost-sharing requirements. Brem Foundation is pleased to partner with AdvaMed to eliminate steep out of pocket costs for physician recommended screening and diagnostics through meaningful policy change that will drive early detection of breast cancer, when health outcomes are best. Together, we’ll be able to improve the lives of women facing a breast cancer diagnosis, no matter what state they call home.”

The post AdvaMed Launches State-focused “Patients First” Agenda appeared first on AdvaMed.

First and only molecular blood test that can both identify bacterial and viral infections and assess need for critical care

SUNNYVALE, Calif., January 21, 2025 /PRNewswire/ —  Inflammatix, a pioneering host response diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the TriVerity™ Test System (TriVerity), a first-in-class molecular test for patients with suspected acute infection or sepsis. Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid and holistic snapshot of a patient’s status. 

Read more.

The post Inflammatix Receives FDA Clearance for First-in-Class TriVerity™ Test appeared first on AdvaMed.

Washington, D.C. – On the Medtech POV podcast , AdvaMed President and CEO Scott Whitaker sat down with Jacob “Jake” Leach, Executive Vice President and Chief Operating Officer at Dexcom, to discuss the latest innovations from the company that provide millions of people easy ways to monitor their glucose levels.

Dexcom products include the G7 Continuous Glucose Monitoring (CGM) system, which is eligible for people ages two and older with any type of diabetes, including type 1, type 2, and gestational, and Stelo by Dexcom, a glucose biosensor for adults with type 2 diabetes who aren’t taking insulin and those with prediabetes, as well as consumers who want to learn more about their glucose health.

Stelo is the first FDA approved glucose biosensor available over the counter and without a prescription. Both devices provide timely, accurate glucose levels without finger sticks, a welcome development in diabetes management.

Leach has worked at Dexcom for almost 21 years and led the development of the evolving, popular technology that has fueled the company’s growth from 30 employees when he started to over 10,000 employees around the world today.

He describes the evolution of complex diabetes management, with finger sticks and calibration required, to a biosensor worn on the arm, connected to a smartphone, without any finger sticks required.

“I think none of us at the time quite understood how impactful this technology would ultimately become,” Leach says. “And as we continue to develop and improve the experience, enhancing things like accuracy, connectivity, and making it easier to use, we see more possibilities. The number of people who can benefit from CGM technology is massive.”

Leach describes the importance of hearing from customers on how the technology has improved their lives and how the customer experience is built into the company culture. Stelo, for example, helps educate customers on the relationship between glucose and diet, sleep, and exercise.

“I was just talking to a Stelo customer who was describing that his physician had told him, ‘you need to get more exercise.’ And so he’s thinking, ‘I need to do a one-hour, hard intensity cardio session.’ But what he learned from wearing Stelo was, really, a walk can do wonders,” Leach says.

In addition to providing personalized insights, CGMs like G7 help users avoid dangerous complications that lead to emergency room visits and hospitalizations. An under-appreciated fact among policymakers is avoiding hospitalization, in addition to serving patients, is a cost savings to the health care system, Leach and Whitaker agreed.

To hear the full conversation, download the Medtech POV podcast on Spotify, Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed’s website for more information on the podcast and past guests.

The Medtech POV podcast is hosted by Scott Whitaker, President and CEO of AdvaMed, the world’s largest medical technology association. It premiered in April 2021 and features interviews with a range of health care experts, medtech leaders, and policy experts. In each episode, Whitaker and guests cover the intersection of medtech and policy from every perspective, including current issues in business, policy, and current events.

The post Medtech POV Podcast Guest, Jake Leach of Dexcom: Glucose Biosensing Provides Value for Patients appeared first on AdvaMed.

BOSTON, January 14, 2025 / —  MedTechVets, a leading nonprofit organization dedicated to helping military veterans transition and find a career with purpose in the Medical Technology  Industry through education, mentoring, and networking, is pleased to announce that Michael  Minogue will be returning as the next Chairman of the Board effective January 14, 2025 for a  proposed term of two years. Mr. Minogue is the founder of MedTechVets and former Chairman of  the organization from 2012-2020.  

Read more.

The post MedTechVets Appoints Michael Minogue as Next Chairman of Board of Directors appeared first on AdvaMed.

Funding will continue supporting VAPOR 2 pivotal clinical study and U.S. commercialization of Vanquish Water Vapor Ablation proprietary prostate cancer treatment

MINNEAPOLIS, January 7, 2025 / — Francis Medical, Inc., a privately-held medical device company developing an innovative and proprietary water vapor ablation therapy for the treatment of prostate, kidney and bladder cancer, today announced the completion of the company’s oversubscribed $80 million Series C equity financing, the largest fundraising round to date for the company.

Read more.

The post Francis Medical Announces Close of Record $80 Million Series C Equity Financing appeared first on AdvaMed.

Washington, D.C. – On the Medtech POV podcast, AdvaMed President and CEO Scott Whitaker sat down with Martina Navratilova and Chris Evert, professional tennis legends who met as teen-age competitors and whose friendship of 50-plus years has deepened over each surviving cancer. The recording occurred in the exhibit hall of The MedTech Conference, where Navratilova and Evert gave a keynote chat moderated by The Washington Post’s Sally Jenkins, who has long covered their careers and friendship.  

Navratilova on tennis competition:  

“I preferred playing people that I liked. Because when I played people that I didn’t like, which thankfully there weren’t that many, I didn’t play that well. I would get tight, but playing a friend, if I won, great. And if I lost, I was happy for them. So it was kind of more of a win-win situation for me that way.” 

Evert on the importance of early cancer screening and follow-up screening after her diagnosis and treatment:  

“Again, it [the diagnosis] was early because I had a CAT scan. The good thing is now, every three months I have a CAT scan. So, if I have anything, they get it early.” 

Navratilova on proton therapy, a highly targeted form of radiation therapy, for her throat cancer: 

“It really saved me because if they had done surgery before [the] proton [treatment], I would have had to learn how to speak again because a big part of my tongue would have been gone.” 

Evert on the importance of listening to your body and going to the doctor if anything feels wrong: 

“A lot of women, I think, wait too long. … They’re used to taking care of everybody else but themselves. They don’t think it’s going to be anything big. And then when it does get big, they’re stage three or stage four. And that’s tough. Then sometimes it’s too late. My message is, you feel anything different in your body, don’t think you’re being a wimp. You just go get a check.” 

On a light note, don’t miss their opinions on pickleball.  

To hear the full conversation, download the Medtech POV podcast on Spotify,  Apple Podcasts or wherever podcast streaming is available. Visit AdvaMed’s website for more information on the podcast and past guests. 

The Medtech POV podcast is hosted by Scott Whitaker, President and CEO of AdvaMed, the world’s largest medical technology association. It premiered in April 2021 and features interviews with a range of health care experts, medtech leaders, and policy experts. In each episode, Whitaker and guests cover the intersection of medtech and policy from every perspective, including current issues in business, policy, and current events. 

The post Medtech POV Podcast: Tennis Legends Navratilova and Evert on Friendship, Competition, and Surviving Cancer appeared first on AdvaMed.