For the millions of people worldwide living with epilepsy, particularly those whose seizures are not controlled by medication, the need for new, safe, and effective therapies has never been greater. Focused ultrasound uses externally applied ultrasound waves focused through the skull to a specific area of the brain to produce therapeutic effects without incisions or radiation. It offers a noninvasive approach that could help meet the needs of those with epilepsy whose seizures are not controlled by traditional approaches. 

Why Focused Ultrasound, and Why Now?
Focused ultrasound is unique in its ability to precisely target brain tissue without incisions. Depending on how it is applied, it can either ablate tissue or modulate neural activity. This opens the door to multiple therapeutic strategies for epilepsy, from removing brain tissue that contributes to seizures to altering dysfunctional brain networks.

At the workshop, it became clear that we as a research community are at an inflection point. Scientific advances, early clinical experiences, and growing cross-disciplinary collaboration are converging to accelerate progress in this field. 

Key Takeaways from the Workshop 

1. A clear unmet need is driving innovation 
Despite the availability of anti-seizure medications, approximately one-third of people with epilepsy continue to experience uncontrolled seizures. Surgical options and implantable devices to modulate brain activity exist, but they are not suitable for all patients. The workshop participants aligned on a critical point: Focused ultrasound could provide a new approach to treating epilepsy and avoid risks associated with medication side effects and surgery.  

2. Neuromodulation is a promising frontier 
While high-intensity focused ultrasound can ablate tissue, much of the discussion centered on low-intensity focused ultrasound (LIFU) for neuromodulation. This approach may allow clinicians to suppress seizures or alter brain networks without permanent tissue damage. This would be an especially appealing option for hard-to-reach brain regions or those involved in critical functions like language and movement. 

3. Targeting and parameters remain key challenges 
One of the most important scientific questions is: Where and how should we intervene? Participants emphasized the need to better define brain regions to target, understand seizure networks, and standardize ultrasound parameters such as frequency, intensity, and duration of stimulation.  

4. Safety and reproducibility must come first 
As with any emerging therapy, safety is paramount. The group highlighted the importance of consistent data capture and reporting standards and rigorous clinical trial design to ensure that results are both reliable and comparable across studies. 

5. Collaboration will determine the pace of progress 
The workshop itself was a powerful example of what is possible when clinicians, researchers, engineers, industry leaders, and people with lived experience come together. Continued collaboration—across institutions and research disciplines—will be essential to move this field forward. 

From Discussion to Action 
One of the most valuable outcomes of this workshop is the recently published white paper, which captures not only the current state of the science but also a roadmap for the future. It outlines priority research areas, from preclinical studies to clinical trial design, and identifies the infrastructure needed to accelerate translation to patients. 

Workshops like this are not just academic exercises—they are catalysts. By aligning on key questions and challenges, we can reduce duplication, focus resources, and move more efficiently toward meaningful breakthroughs.  

Looking Ahead 
At CURE Epilepsy, our mission is to fund and accelerate research that leads to cures. Focused ultrasound represents an exciting and rapidly evolving area that aligns closely with that mission. We were excited to announce a co-funded Catalyst Award with the Focused Ultrasound Foundation that will test whether low-intensity focused ultrasound can transiently modulate activity in brain regions involved in seizure generation or propagation. 

What gives me the greatest hope is not just the technology itself, but the researchers and momentum behind it—the shared commitment, the urgency, and the willingness to tackle hard problems together. 

There is still much work to be done. But if the energy and insight from this workshop are any indication, the path forward is becoming clearer—and the potential impact for people living with epilepsy is profound.

Dr. Lubbers has been the chief scientific officer at CURE Epilepsy since 2017.

Investigators and clinicians at two centers performing focused ultrasound treatments for brain disorders recently reported unexpected and significant AEs in three patients. Serious AEs are a rare occurrence with focused ultrasound brain treatments, and the Foundation extends sympathy to the patients and families affected by these unusual events. 

Summary of Reported Events 
On October 31, investigators at the West Virginia University (WVU) Rockefeller Neuroscience Institute wrote a letter to the editor of the journal Brain Stimulation describing an AE due to micro-hemorrhages and edema within and beyond the target area that led to loss of consciousness, intermittent confusion, poor memory recall, and other signs of brain injury. The AE occurred when low-frequency focused ultrasound neuromodulation was being administered in a clinical trial participant undergoing treatment for substance use disorder. 

A few days later in early November, two serious AEs were reported in patients in Madrid, Spain—one with essential tremor and one with Parkinson’s disease. Both patients had developed symptomatic brain hematomas while undergoing focused ultrasound ablation procedures at the Centro Integral de Neurociencias (HM CINAC). These AEs were reported in CNS Neurosurgery. 

Both centers were using Exablate Neuro focused ultrasound devices manufactured by Insightec, but one was a low frequency device (predominately used for blood-brain barrier opening) and the other was high frequency (used for ablative lesioning). The AEs appeared to be associated with the presence of unwanted and unexpected inertial cavitation, which is described by The American Institute of Ultrasound in Medicine (AIUM) as sudden and violent bubble collapse that can potentially damage biological structures. 

Researcher Response 
Two focused ultrasound researchers with technical expertise formally responded about the WVU neuromodulation case. Kim Butts Pauly, PhD, professor of radiology at Stanford University, and Elsa Fouragnan, PhD, professor of neuroscience at the University of Plymouth, each wrote a letter to the editor of Brain Stimulation to share their professional insights on this issue. Importantly, their letters stressed how critical it is to report all power and parameter settings when delivering ultrasound energy to patients, as one publication above originally did not, citing that including some proprietary settings was prohibited by the manufacturer. With transparent reporting, investigators and collaborators could identify which parameter combinations contributed to these AEs and take steps to prevent similar events in the future. 

While maintaining proprietary information is important, because we need successful businesses to make results widely available to patients, it should not take precedence over patient safety. If one treatment site identifies a problematic power setting or monitoring issue, ethical responsibility dictates that this information be shared so that similar AEs are not repeated. 

After working with the clinical trial sponsor, the WVU group published additional information to include all ultrasound parameters, further context on the clinical trial, and “the role of acoustic feedback as a safety mechanism.” The Foundation is supportive of this publication, which provides expanded knowledge of the event and enables the entire field to understand it as treatments continue to evolve.  

Focused Ultrasound–Specific Safety Recommendations and Standards 
Unwanted side effects and AEs in the use of both high- and low-frequency focused ultrasound can be decreased by the advancement and adoption of safety standards that are specific to the field. 

Currently, the regulatory standards related to cavitation apply only to diagnostic ultrasound imaging. In therapeutic ultrasound applications, however, the exposure parameters—especially frequency, along with pulse length, pulse repetition, skull characteristics, tissue properties, and the absence of contrast agents—differ substantially from diagnostic settings and may require consideration of additional factors beyond acoustic pressure alone. 

Several organizations have been working to develop recommendations and safety standards for ultrasound devices, including AIUM, the International Transcranial Ultrasonic Stimulation Safety and Standards (ITRUSST), the National Electrical Manufacturers Association (NEMA), the Institute of Electrical and Electronics Engineers (IEEE), and the International Electrotechnical Commission (IEC). Learn more about some of these efforts below under Recommended Reading. 

Foundation Efforts and Next Steps 
The Foundation encourages investigators to continue pioneering new treatments—as the diseases we are treating also have significant impacts on patients’ lives—while widely sharing the successes and the unavoidable failures. Managing this process well minimizes risks to patients in clinical trials while simultaneously advancing the development of this important technology. 

Because we do not yet have standards for all therapeutic ultrasound applications, reporting all exposure conditions (including power settings) is paramount as the field strives to establish its safety standards. 

The Foundation remains committed to safe and effective clinical adoptions while supporting standardization efforts by incorporating relevant input from the field. 

Beyond brain applications of therapeutic ultrasound, AIUM and the Foundation hosted a series of cavitation monitoring workshops in 2021. Based on that series, an independent working group drafted a technical specification on cavitation detection and monitoring for different applications of focused ultrasound, including blood-brain barrier opening, histotripsy, and drug delivery — all with or without injected cavitation agents. The first draft was presented during the October 2025 IEC meeting and will be advanced as a new work item at IEC’s Spring 2026 meeting. 

The Foundation’s Research Director for Applied Physics, Frédéric Padilla, PhD, and Gail ter Haar, PhD, first published Recommendations for Reporting Therapeutic Ultrasound Treatment Parameters in 2022. 

Tim Meakem, MD, is the Foundation’s Co-Director of Research and Education. 

Known as “America’s Seed Fund,” the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have helped thousands of early-stage companies develop new ideas with support from the US government. These initiatives fall under the umbrella of the US Small Business Administration, but the majority of SBIR/STTR funding comes from the Department of Defense (DOD) and the Department of Health and Human Services (HHS), which includes the National Institutes of Health (NIH). However, these important programs are now at risk. 

Between 1985 and 2022, SBIR and STTR provided more than $40 million for small businesses developing innovations in focused ultrasound technology.   

This year, the US had the longest government shutdown ever, lasting 43 days. When the government reopened, only a few parts — such as the Legislative Branch, the Department of Agriculture, and the Military Construction-Veterans Affairs — were fully funded for the next full fiscal year. The rest of the government received only temporary funding until January 30, 2026. Therefore, current NIH and other agency SBIR/STTR projects can continue to receive funding only until the end of January.  

However, the reauthorization of the SBIR/STTR programs was not part of the bill to reopen the government, so they officially expired on September 30, 2025. As a result, small businesses cannot apply for new SBIR/STTR funds until these programs are officially renewed. Some future NIH funding opportunities, put out as Notices of Funding Opportunity (NOFOs), have now been expired: Click here for the list. NIH cannot issue noncompeting continuation awards for existing projects until the programs are reauthorized. 

Together, SBIR and STTR have funded approximately 5,000 new awards each year. It is essential for organizations working in focused ultrasound – and other innovative companies – to continue to receive funding through SBIR and STTR to develop life-saving treatments and increase the quality of life for patients. 

Learn more about SBIR and STTR Programs in Jessica Foley’s 2024 blog post. 

Reach Out 
If you have been affected by the lapse in SBIR/STTR funding, we want to hear from you. Please reach out to Cindy Clark, director of commercial initiatives and strategy at cclark@fusfoundation.org. 

Cindy Clark works with the FUS Partners team as Commercial Initiatives and Strategy Director. She is a serial entrepreneur with more than 25 years of successful commercialization experience in the life science industry.

Jessica Chao is the Asia Ambassador for the Focused Ultrasound Foundation and a member of the Foundation’s Council. Based in Taipei, Taiwan, she coordinates Foundation-related activities across the region and maintains a strong local presence in collaboration with her colleague Dong-Guk Paeng, PhD, in Korea.

Jessica also serves as director of the Focused Ultrasound Hong Kong Foundation Limited (FUSHK) and has worked in different capacities in the financial industry for 15 years–across banking, equity research, and strategic investment. Most recently, she was an executive director of firmwide strategy at Goldman Sachs (Asia) based in Hong Kong.

We recently spoke with Jessica about her role advancing focused ultrasound in Asia.

Can you share more about your role with the Foundation?
As the Ambassador for the Foundation in Asia, I’m the key coordinator responsible for all Foundation-related activities and company liaison in that region. I’m based in Taipei, Taiwan. We have another ambassador, Dong-Guk Paeng, PhD, who’s based in Korea, and together, we maintain a very strong and localized presence in the key parts of the region.

How was FUSHK founded and what are its priorities?
The FUSHK was founded in 2020 as part of a strategic initiative to expand the Foundation’s footprint in Asia. And from the beginning, the Foundation envisioned itself as a global organization with the mission to save and improve lives of patients worldwide. Asia is home to a lot of growing innovative startups in the focused ultrasound space, particularly in places like Taiwan, China, and Korea. It’s important for us to provide friendly, timely support for companies and researchers in that region.

Can you highlight a few of the exciting developments in the focused ultrasound field in Asia right now?
The most exciting part of the focused ultrasound field in Asia is clinical adoption. Chongqing Haifu is a flagship manufacturer in focused ultrasound, and I believe its devices have treated the most patients worldwide. On the smaller scale, we are seeing a lot of new startups going into this field. There are also more indications that are being studied and adopted in Asia than in the rest of the world.

What is one thing you want readers to take away from this blog?
The US and Hong Kong Foundations are really here to help. We provide support, not just financially, but also in advice to newcomers who want to get into this field. If you have any questions, feel free to reach out to us. Our mission is to save lives, and together, we want to make this happen.

Get in touch
Find out more about the US-based Focused Ultrasound Foundation and focused ultrasound. To learn more about FUSHK and the resources they provide, visit the website or contact hkinfo@fushk.org.

Watch the Interview

Interested in learning more about focused ultrasound and the people who are advancing the Foundation’s mission? Listen and subscribe to our Curing with Sound podcast for more in-depth conversations with patients, medical experts, partners, and Foundation staff.

The recent landmark acquisition of HistoSonics, a leader in focused ultrasound devices, is the most significant milestone in the evolution of the field to date—and a case study in how medical innovation works when government and private capital are combined.   

HistoSonics successfully commercialized histotripsy – a technique that uses focused ultrasound to noninvasively liquify target tissue in the body without heat. The company’s Edison system has US Food and Drug Administration clearance to treat liver tumors and is now being tested in clinical trials to address kidney, prostate, and pancreatic tumors. In all, Edison has already been used to treat more than 2,000 patients at over 50 active centers worldwide—and that number is quickly increasing. 

Its recent sale and status as a unicorn company (a startup valued at over $1 billion) positions HistoSonics as the North Star in the field of focused ultrasound. It will continue to improve the lives of countless patients and help guide future companies along the path to commercial success. The company will also create wealth for numerous investors and new jobs, thereby improving the economy. 

Federal Funding Sparks Medical Innovation 
Histotripsy was first discovered and researched at the University of Michigan by the late Charles Cain, PhD, and Zhen Xu, PhD, the Li Ka-Shing Endowed Professor of Biomedical Engineering and Professor of Radiology and Neurosurgery. That work was funded by ten independent R01 grants from the US National Institutes of Health (NIH), totaling more than $30 million. R01 grants are the standard independent research project grant awarded by NIH for health-related research and development.  

Other philanthropic organizations, including the American Cancer Society, the Hartwell Foundation, and the Focused Ultrasound Foundation, also supported this early research.  

Only after 20 years of federally supported research was the science ready for private investors to scale and commercialize.  

Impact of Research Funding Cuts  
Since January, the current US administration has terminated more than 800 research projects and cut billions in NIH funding for future studies. These decisions put the future success of innovative healthcare companies – like HistoSonics – at risk. Without early-stage investment from the government, transformative technologies rarely leave the laboratory, creating a significant missed opportunity for critical economic development. Most urgently, patients also lose access to potentially life-saving treatments. 

Public funding lays the foundation for private sector growth. Erode that base, and we weaken America’s ability to lead in the life sciences and compete in the global economy. And we risk lives.

In 2018, the US Food and Drug Administration (FDA) established the Breakthrough Devices Program to allow fast-tracking of certain novel devices. The program offers device manufacturers an opportunity to work directly with the FDA through the premarket review stage of the approval process. The overall goal is to expedite patient access to devices that provide more effective treatment or diagnosis – through a more rapid assessment and review process – while preserving the FDA’s standards of approval. 

On its website, the FDA describes the program, how to apply, and the benefits of receiving Breakthrough Device Designation (BDD). The process for submission is straightforward, and the response time for a request is relatively short (within 60 days). Also notable, the required clinical data bar is low, and the benefits to receiving BDD are many.  

How many devices have Breakthrough Device Designation? 
As of September 30, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) and the FDA Center for Biologics Evaluation and Research (CBER) have granted 1,041 BDDs, including devices that were originally included in the FDA’s Expedited Access Pathway Program. Of the 1,041 devices granted BDD, CDRH has granted 1,029 of them, and CBER has granted 12 of them. There are eight companies that have received BDD for focused ultrasound applications, which is a large number given the relative newness of the field. A BDD request can be submitted any time before submitting any type of FDA marketing submission (PMA, premarket notification [510(k)], or De Novo classification request).  

How do you apply? 
BDD is requested by submitting a “Designation Request for Breakthrough Device” Q-Submission through the FDA electronic portal (CCP – Sign In). A submission can be made through either the electronic Submission Template And Resource (eSTAR) or eCOPY, as described below.  

eSTAR is an interactive PDF document that guides applicants through the process of preparing a comprehensive medical device submission and automatically tracks the status of the document preparation. This is especially helpful when preparing a detailed submission, such as a request for a Q-presubmission meeting or a regulatory document submission (510(k), PMA, etc). There are different eSTAR forms depending on the type of submission, available here. 

eCOPY is a means for electronic submission of other interactive material, such as BDD submission, and follow-up questions to an eSTAR submission, etc. eCOPY requires any communication be converted to a zipped pdf format before submitting—the individual documents are placed in a folder on a computer which can then be “zipped” within the file viewer. eCOPY is the recommended method for BDD submission and the easier one to use. 

The FDA provides automated status updates on materials submitted through eSTAR and eCOPY. 

Why Breakthrough Device Designation? 
BDD is not an alternative path to regulatory authorization, nor does it alter the likelihood of a device receiving regulatory authorization. It does, however, offer many benefits to companies, including: 

• streamlining the regulatory process 
• allocating more FDA resources to the company 
• facilitating faster communications between companies and the FDA 
• creating a “binding” agreement on regulatory clinical trials 
• prioritizing the company when it comes to the allocation of increasingly limited FDA resources 
• carrying a certain amount of cachet with investors and the public  

With eight focused ultrasound companies earning BDD to date, the program is shaping up to play a major role in helping to advance the commercialization of the technology. BDD was designed to help new technologies or innovations move more quickly through the regulatory process to get potentially life benefitting treatments to patients more rapidly. Given the potential focused ultrasound has to aid patients with currently untreatable or poorly treatable conditions – and given the propensity the FDA has shown in granting focused ultrasound technologies BDD across varied uses – companies in this space are encouraged to consider this path as they explore regulatory options for either new technologies or new uses for existing devices. 

More Resources 
For a first-hand account of a focused ultrasound company navigating the Breakthrough Devices Program, read “An Inside Look at Obtaining Breakthrough Device Designation.” 

Visit the FDA Breakthrough Devices Program Website 

Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.  

One Medicine recognizes the fundamental similarities between veterinary and human medicine, emphasizing the interconnectedness of animal and human health. This concept predates a similar idea known as “One Health,” which acknowledges the interdependence of animals, humans, and the environment in shaping health outcomes. With growing awareness of zoonotic diseases—those transmitted from animals to humans—One Health has gained public health significance, particularly in addressing threats like West Nile Virus, COVID-19, and antibiotic resistance. Conversely, One Medicine maintains its focus on diseases that naturally occur in both humans and animals, such as cancer and obesity. 

My introduction to the concept of One Medicine began during my clinical research at Oklahoma State University’s (OSU) College of Veterinary Medicine. Primarily funded by the National Institutes of Health, my work focused on exploring human health through veterinary clinical trials. These trials underscored striking similarities between canine diseases and those found in humans, and this research—along with similar work from the larger university faculty community—was the basis for establishing the OSU Institute for Translational and Emerging Research in Advanced Comparative Therapy (INTERACT). The Focused Ultrasound Foundation has been a proponent of this approach and supported our initial INTERACT Symposium in 2021.  

It was during this symposium that I learned about Robert Timmerman, MD, Chair of the Department of Radiation Oncology at UT Southwestern (UTSW), and our mutual interest in the One Medicine concept. We spoke about the idea of researching both human and veterinary diseases under the same umbrella—inspiring the creation of a first-of-its-kind clinic that we have named the Veterinary Research and Oncology Clinic (VROC).  

UTSW’s VROC is set to open in early May 2025. The revolutionary space will not only be a center of cutting-edge veterinary research but will also be one where innovative treatments are simultaneously tested in both human and animal clinical trials. The clinic will integrate many disciplines, including radiation therapy, oncology, and several other fields of medicine. This collaborative approach between human and veterinary medicine is unprecedented and marks a significant step forward in medical research and treatment; for this, I applaud UTSW.  

Personally, I am most excited about the potential impact of VROC as it promises to break down the existing silos between human and veterinary medicine. Enabling human and veterinary clinicians to collaborate in shared work environments, devising innovative clinical trials, and leveraging their combined knowledge to enhance our understanding of diseases affecting both animals and humans, all while facilitating the development of new treatments and therapies, represents a truly exciting innovation. VROC will have access to two focused ultrasound devices: the ALPINION system and the HIFUPlex Elite device, which the Foundation partnered with Verasonics and Sonic Concepts to develop. We will have a radiation oncologist, a medical oncologist, a staff veterinarian, medical physicists, a chief radiation therapist, a radiation therapist, five to eight technicians, and a clinical trials coordinator. We aim to be the first clinic in the nation to have a dedicated focused ultrasound therapist to help conduct the treatments. Additionally, we hope to continue partnering with the Foundation to expand our focused ultrasound research.  

The Foundation has been a consistent source of support throughout my journey at OSU and now at UTSW. It has also been pivotal in helping to establish cross collaborations with major veterinary practice networks—a crucial step toward the clinic’s growth. I am deeply grateful for the Foundation’s invaluable contributions to this field. 

We will hold a symposium on June 23, 2025. The symposium, which is designed for researchers, clinicians, residents, and students from both human and veterinary medicine, aims to deepen understanding of the reciprocal significance of veterinary clinical trials in human medicine and vice versa across diverse disease domains. We believe that the symposium will foster collaboration, encourage cross-disciplinary exchanges, and inspire a cultural shift in medical research and practice by reimagining the traditional translation of drugs and therapeutic devices from preclinical to clinical settings using smart approaches. Our day-long symposium will feature lectures, roundtable discussions, and presentations by graduate students and postdoctoral researchers. 

VROC embodies a paradigm shift in health care, underscoring the collaboration between human and veterinary medicine. As Dr. Timmerman aptly puts it, “It can leapfrog rodent research quickly to clinical trials, bringing cancer research products faster to patients.” By harnessing expertise from both human and veterinary medicine, we can more effectively tackle complex health challenges, paving the way for this innovative approach to medicine. 

Ashish Ranjan, PhD, is an Endowed Professor in the Department of Radiation Oncology. He also serves as Vice Chair for Comparative Oncology and Research Innovation and Director of VROC at UTSW.

The programs come in many different flavors. Incubator and accelerator programs can be non-profit or for-profit. Some offer standard in-person courses for several weeks or months. Others offer virtual programs or customized programs. We’ve assembled a list of some of the incubators and accelerators throughout the world that have expertise in medical devices in the table below. 

Incubators and accelerators can provide a wide variety of much-needed resources for early-stage medical device companies, including brick-and-mortar resources, professional services, networking opportunities, and some even provide capital. According to the International Business Incubation Association, companies that participate in these programs are 43% more likely to be successful than companies that do not.  

Participating companies can have access to a number of advantages, such as: 

• Reduced costs for shared facilities like lab equipment, supplies, IT, and rent. 
• Expertise from staff on numerous topics, including legal, accounting, intellectual property, regulatory, and reimbursement. 
• Network of investors, strategic partners, consultants, and clinical sites. 
• Shared experiences with other participating companies. 

When evaluating which program may be the best for your company, here are some aspects to consider: 

• Location. If your company is not already in the same location as the program, how expensive, distracting, and inconvenient would it be for some or all of your team to be there? Location can also impact funding, which can be easier to raise in certain cities, states, and countries. Could a virtual option be more appealing? 
• Stage of Development. Evaluate whether the program is suited to your company’s stage of development. 
• Services and Facilities. Although some programs do not require an equity share, some of them do. If so, ensure that the value of services and facilities provided by the program are worth the value of the equity required to be given to the organization to participate in the program. 
• Reputation. Participating in a well-known, successful program can add to the company’s credibility. A program’s negative reputation can make it more difficult for the company to raise capital in the future. 
• Success Rate. Check out the success rate for prior participants/graduates. How much money did they raise? What is the exit rate? What is the average length of time to graduation? 
• Network. Look at the program’s networking capabilities. Which strategic partners are actively involved? If a program is dominated by one large company, does that fit with your exit strategy? How successful is the investor network? Does the program have connections to health systems, clinical sites, patient advocacy organizations, manufacturing? 
• Cultural Fit. Evaluate the cultural fit for your company and your team with the mentors and other companies participating in the program. Is the mentor(s) an expert in medical device development and your therapeutic area? Determine whether the culture and values of the program align with your company’s mission and team dynamics. Are the other companies close competitors (which could make participating in group activities more challenging)? Do they have some synergy with your business so you can learn from shared relevant experiences? 
• Focus/Distraction. Review the program’s curriculum, workshops, events, and milestones. Are they directly aligned with critical steps in your commercialization pathway? If the program is too general or focused on things that are not on the critical path, evaluate how participation could distract the team from what needs to get done in the short term for success. 

If you would like more information about incubators and accelerators, email the FUS Partners team at fuspartners@fusfoundation.org. 

Additional Resources:  
Gomez, M.E. 10 Accelerators and Incubators Revolutionizing Medical Device Innovation (1/7/2025) https://hattrick-it.com/blog/10-accelerators-and-incubators-revolutionizing-medical-device-innovation

Kaufman Foundation Entrepreneurship Issue Brief 2020: No. 2. Measuring Accelerator Performance: Potential Metrics and the “4Cs”. https://www.kauffman.org/wp-content/uploads/2021/07/Kauffman_Issue-Brief_Measuring-Accelerator-Performance_2020.pdf  

Sriram, R. 11 Best Medical Device Incubators and Accelerators in the US (1/9/2020) https://www.kolabtree.com/blog/best-medical-device-incubators-and-accelerators-in-the-us/ 

Thibault, M. 26 Medtech Incubators and Accelerators You Need to Know (5/19/2017) https://www.mddionline.com/business/26-medtech-incubators-and-accelerators-you-need-to-know

Tippmann, N. Ultimate List of Medical Device Incubators and Accelerators (50+) (1/12/2018) https://www.greenlight.guru/blog/medical-device-incubators-accelerators

Medical Device Incubators and Accelerators 
(2025)

The reimbursement level that a facility receives for the treatments it performs is referred to as the payment. Payment rates at ASCs are generally lower than those for hospital outpatient facilities due to lower operating costs. This blog will explore how ASC payments are determined and how companies can price their devices accordingly. 

How are ASC payments calculated? 
The first thing to remember is that payments are tied directly to costs. CMS determines how much it will pay based on how much the procedure actually costs to deliver in the hospital outpatient setting; CMS only looks at the actual hospital outpatient setting costs, not the costs in an ASC.  

Second, while most ASC payments are based on the Hospital Outpatient Prospective Payment System (OPPS) rate, some ASC procedures are also based on Medicare Physician Fee Schedule (PFS) non-facility payment rates. The determining factor is where the bulk of the procedures are performed. If the bulk are performed in the ASC or an outpatient facility, then the payment is based on the OPPS rate. However, if the bulk of procedures are performed in a physician’s office, then payment is based on the PFS rate. This discussion will focus exclusively on ASC and outpatient facility–dominant procedures that adhere to the OPPS rate. 

The conversion factor for the payment of a procedure performed in a hospital outpatient department (OPPS rate) for 2024 was $87.382. Meanwhile, the conversion factor for an ASC payment was just $53.514. This means the ASC payment rate is 61% of the payment rate for the same procedure done in the hospital outpatient department under OPPS. 

Device-Intensive Procedures  
Another factor to consider is that the actual payment to an ASC depends on whether the procedure is considered ‘device intensive.’ To determine whether a procedure falls into this category, one must calculate a device offset percentage. The device offset percentage is the cost of the device divided by the total outpatient facility cost of the procedure which is reported to CMS by only hospital outpatient facilities (the facility costs plus device costs). If the offset is greater than 30%, then the procedure is considered ‘device intensive.’  

ASC-referenced procedures that are not device intensive are paid at 61% of the OPPS payment amount. However, if the procedure is device intensive, it gets paid more. How much more is determined by the cost of the device. Remember, this is true only for ASCs and not for a hospital outpatient facility.  

If a procedure is device intensive, the ASC gets paid for the cost of the device plus 61% of the OPPS payment for the work done using the device.  

Device Non-intensive: Total payment = 61% of total OPPS payment 

Device Intensive: Total Payment = 100% of device payment + 61% of OPPS procedure related payment 

A Case Study 
In this example, let’s assume that a device costs the facility $4,000 per patient and the procedure using that device costs an additional $900 to perform.  

If this procedure is performed in a hospital outpatient facility, the total cost for the procedure would be $4,900 ($4,000 + $900). The hospital would receive an OPPS payment of $4,900. This procedure is considered device intensive because the device costs more than 30% of the total cost of the procedure ($4,000/$4,900 = 82%). Therefore, if this procedure is performed in an ASC, the ASC would get paid $4,000 for the device portion of the procedure and 61% of the $900 facility procedure cost, or a total of around $4,500. 

Now let’s look at a procedure that is non-device intensive. Here, the device costs just $900 and the rest of the procedure costs of $4,000.  

The total cost is the same for the hospital outpatient facility ($4,900), and the OPPS payment would be $4,900. However, if the procedure is performed in an ASC, the payment rate would be 61% of the total OPPS payment, or around $2,970.  

In summary, for two procedures each with a total costs $4,900: 

Device Non-intensive Payment 

$4,900*61% = $2,970 

Device Intensive Payment 

$4,000 + 61% *$900 = $4,500  

Whereas the payment for the device intensive procedure may well cover the cost of performing the procedure, since actual ASC costs are less than OPPS costs, it is possible that even with those lower costs the payment for a device non-intensive procedure may not over the actual costs. 

Take Home Message  
These case studies demonstrate how device-intensive procedures generate more revenue for the ASC than device non-intensive procedures. Therefore, for device manufacturers, it is important to consider the implication of device pricing when bringing the product to market. If it turns out that the payment to the ASC will significantly underpay the actual costs of performing the procedure, then it is unlikely the procedure will be performed. 

It is important to remember that all payment rates are based on outpatient facility Medicare claims. If the preferred place of use for a device is going to be an ASC, it may be beneficial to start in the hospital outpatient facility to establish a favorable reference point. In addition, serious consideration must be given to the single patient device cost relative to the total cost of the procedure. In this way, when the procedure is transitioned to the ASC setting, the payment rate will be sufficient for the ASC to pay for the device and its own facility costs. 

Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.  

The opinions in this article are not necessarily reflective of those of the Focused Ultrasound Foundation.

Since its inception, the Focused Ultrasound Foundation has explored in detail the regulatory and reimbursement paths for focused ultrasound treatments that involve capital equipment. The regulatory process for a wearable or home-based solution is the same as that for capital purchases; however, at-home products have a different reimbursement path than that of capital equipment because they are considered durable medical equipment (DME). This blog presents an introduction to that path, an understanding of which is important for manufacturers, providers, clinicians, and patients.

Durable Medical Equipment (DME)
In order to be classified as DME, the Centers for Medicare and Medicaid Services (CMS) requires a device to meet ALL of the following criteria:

• Durable (able to withstand repeated use by more than one patient)
• Primarily and customarily used for a medical reason
• Generally not useful to someone unless they are sick or injured
• Is appropriate for use in the home (outside of a treatment center)
• Expected to last at least three years

Again, for a device to receive a DME designation, it must meet all five of the above criteria. Wearable and home-based technologies are typically classified as DME. Examples of DMEs are wheelchairs, nebulizers, ventilators, and blood sugar meters.

Multi-Component Devices
Sometimes, a product may include a component that meets the definition of a DME along with a component that does not. CMS defines a multi-component device as one consisting of durable and nondurable components that together serve a medical purpose. An example of this is if the device requires a disposable that cannot be used by a second patient.

A multi-component device cannot be classified as a DME if the component that performs the medically necessary function of the device is non-durable. This is true even if other components that are part of the device meet the DME requirements.

In other words, if the portion of the multi-component device that is at the core of the device is durable, the entire device is durable.  It is possible that a wearable therapeutic ultrasound device that requires the use of a daily disposable component to secure the device to the patient may be considered a DME because the active component is a DME.

Coding Process
The Healthcare Common Procedure Coding System (HCPCS) is a complex standardized coding system to ensure Medicare and other health insurance programs can process claims in an orderly and consistent manner. When new devices enter the market, manufacturers can request a new HCPCS code or an amendment to an existing HCPCS code description. The application process for DME designation and an associated HCPCS code occurs twice a year, generally around January 1 and July 1. After CMS makes a preliminary decision on the application – which can include denying DME status, placing the device under an existing DME HCPCS code, or issuing a new HCPCS code – it holds a public meeting during which applicants and the public can present more information confirming or challenging CMS’s preliminary decision. CMS then makes a final decision.

It is considered extremely difficult to obtain a new HCPCS code because, rather than issuing a new code, CMS has adopted the policy of modifying existing HCPCS codes whenever possible to make them more generic. It is important to note that all payers, not just Medicare, generally follow CMS’s HCPCS code decisions.

The application for a DME payment code is on the CMS website at: https://www.cms.gov/medicare/coding-billing/healthcare-common-procedure-system.

Pricing
Contrary to the payment rate for capital equipment, which is based on claims data submitted by hospitals for performing procedures that use the equipment, DME reimbursement pricing is established based on how much the manufacturer is paid for the DME.

If a new device falls under an existing DME HCPCS code, then it is priced at the established rate for that code regardless of how much the new device costs.

For a new code, the fee schedule for items and services are dependent on pricing history, if it exists. This history is submitted to CMS using data on payments made for the items. Historically, supplier price lists, including catalogs and other retail price lists, could be used to provide information on commercial pricing for the item. However, in 2019, CMS issued a final rule that set regulations for establishing payment amounts for new DME items and services, stating that it would no longer use the manufacturer’s suggested retail price (MSRP) to set the fee schedule rates. Rather, CMS would rely on fees actually paid for the item. Potential appropriate evidence of commercial payments can include those made by Medicare Advantage plans, verifiable information from supplier invoices, and non-Medicare payer data, including cash pay by patients.

If there is no price history, then pricing is delayed until a history can be established.

Payments
Unlike capital equipment, which is purchased and paid for by the acquiring institution or facility, payments to DME suppliers are made on a monthly rental/purchase basis by the insurer. Although it varies, in general a DME is paid as a rental and used by a single user for up to 13 months. If the user requires the equipment longer than that, the equipment is considered fully purchased by the user after the 13th month.

CMS and most providers pay 10% of the determined total fee for the DME for each of the first three months, then 7.5% for each of the next ten months (totaling 105%), after which there is no further reimbursement for that specific piece of equipment. After 13 months, the DME is considered “purchased” and owned by the user. The supplier must transfer title of the item to the beneficiary (patient) on the first day after the 13th continuous month in which payments are made. Suppliers must also offer a purchase option to beneficiaries beginning during the 10th continuous rental month. If there is a disposable component to the equipment, the fee associated with that component will continue to be paid monthly to the supplier after the 13th month if the patient continues using the DME.

It is important to note that CMS does not determine whether or not a fee for the technology is appropriate. It does not evaluate the cost effectiveness of the equipment or whether the determined fee is, for instance, too high relative to the cost required to manufacture the equipment. Commercial insurance carriers, on the other hand, may make such a determination and elect not to pay for a DME if the carrier determines it is too costly.

If there is a disposable or non-durable component to the equipment that falls under an established HCPCS code for that component, it is paid at the fee assigned to that code regardless of actual cost. These fees are assessed annually and may fluctuate depending on the data submitted to CMS regarding the amounts paid for a component covered by a given code. Payment for a disposable or non-durable component that requires a new HCPCS code is priced the same way the payment rate for the durable portion of the equipment is set.

Note that at times, when CMS issues a new DME code, that code may also include the cost of the disposable.

DME Maintenance and Servicing
Since DME is treated as a rental for the first 13 months of use, the supplier is responsible for servicing and maintaining the equipment. This cost should be factored into the amount charged for the DME. After ownership transfers to the patient, CMS will pay for maintenance and servicing of the DME. The amount that CMS will pay depends on where the device is located. If the specific local payment amount (the amount for the geographic region) for maintenance and servicing is between 85% to 100% of the median of all local payment amounts (the entire country), CMS will pay 100% of the specific local payment amount. If the local payment amount does not fall within that range of the median, CMS will pay 85% of the median of all local payment amounts.

Conclusion
There is a growing number of manufacturers who are looking to bring to market therapeutic ultrasound technologies designed for home use either continuously or intermittently. These technologies have the potential to treat chronic diseases and illnesses that cannot be addressed by a single intervention. They could also help demonstrate that therapeutic ultrasound is a safe and noninvasive tool while increasing the number of patients who could benefit from the technology.

CMS has developed a specific reimbursement mechanism for covering the costs associated with such technology, namely one that effectively pays the manufacturer directly over an extended period. This approach is different than the typical one whereby the manufacturer receives payment upfront for the capital costs associated with their technology, plus ongoing payments for any single patient use items. DME designation makes it possible to receive adequate payment for a non-capital-intensive device that, when coupled with the large unit placements typical of home solutions, can generate a significant financial return. An early understanding by the manufacturer as to how DME devices are priced and paid will help the company design, develop, and package its technology in such a way as to improve the likelihood of product and corporate success when the device comes to market.     

Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.