Rebecca King Crews, a singer and fashion designer, first noticed concerning numbness and coordination symptoms in 2012, which were initially dismissed as anxiety. However, after symptoms persisted, she was diagnosed with Parkinson’s disease three years later. She experienced significant tremors that made daily tasks like putting on makeup and brushing her teeth a challenge.

King Crews and her husband, Terry Crews, an actor and host of America’s Got Talent, appeared on the Today Show to share her diagnosis and results from her focused ultrasound treatment. After undergoing an MR‑guided focused ultrasound procedure using the FDA‑approved Exablate Neuro system (Insightec) at Stanford University, King Crews has noticed significant symptom relief on the treated side of her body. She noted, “I’m able to write my name and my dates, and I’m able to write with my right hand for the first time in probably three years.”

She plans to undergo a second focused ultrasound procedure on the other side of her brain in the coming months and calls focused ultrasound and other innovative procedures “the new frontier of medicine.”

Watch the Today Show Segment

Read the Article on People.com

*Note: The segment states that focused ultrasound for Parkinson’s disease is not yet covered by insurance, which is possibly misleading. Below is the current status for the various focused ultrasound procedures for Parkinson’s patients.

Symptom: Tremor (shaking)
Focused ultrasound pallidotomy targeting the ventral intermediate nucleus (or ‘VIM’) is FDA approved and:
• Covered by Medicare in 38 states: AK, AL, AZ, CA, CT, GA, HI, IA, ID, IL, IN, KS, KY, MA, ME, MI, MN, MO, MT, NC, ND, NE, NH, NV, NY, OH, OR, RI, SC, SD, TN, UT, VA, VT, WA, WI, WV, and WY
• Also covered by some private insurers, including Aetna, Blue Cross Blue Shield of Rhode Island, MetroPlus Health Plan, PacificSource Health Plans, and Priority Health Michigan

Symptom: Dyskinesia (a broader family of motor symptoms, including bradykinesia, rigidity, and tremor)
Focused ultrasound targeting the internal portion of the globus pallidus (GPi) is FDA approved and:
• Covered by Medicare in 10 states: CT, IL, MA, ME, MN, NH, NY, RI, VT, and WI 
• Also covered by some private insurers, including Anthem, Healthlink, and Unicare

Advanced Motor Symptoms (mobility, rigidity, dyskinesia)
Focused ultrasound targeting the palliothalamic tract (PTT) is not currently covered by insurance.

To learn more about where you can access focused ultrasound for Parkinson’s disease, see a list of treatment sites.

• The Carolinas Pain Institute was the site of the first commercial treatment using FUSMobile’s Neurolyser device.   
• The device earned US FDA clearance in November 2025, and the company is now working to expand access to patients.  

FUSMobile recently announced its first commercial patient treatment in the US. Using the Neurolyser XR system, the low back pain treatment was performed by Leonardo Kapural, MD, PhD, at the Carolinas Pain Institute (CPI) in Winston-Salem, North Carolina. While the CPI is the first site in the US offering the treatment outside of a clinical trial, others are in the process of being added.  

The Neurolyser XR is a first-of-its-kind device. Guided by x-ray fluoroscopy imaging, it applies high-intensity focused ultrasound to heat and destroy sensory nerves in the spinal facet joints. These nerves are a leading source of chronic low back pain, which affects millions of adults. Clinical data suggested that this noninvasive approach reduced patient discomfort and post-procedure pain compared with traditional interventional methods, such as steroid injections and radiofrequency denervation. 

The device was granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain in November 2025. This means the FDA has authorized the device as safe and effective, established it as a new category of treatment, and cleared it for marketing in the US. The Neurolyser XR also has also been granted the CE Mark in the European Union, Health Canada approval, and is registered in the UK. 

In the company’s press release, Arik Hananel, MD, MBA, co-founder of FUSMobile, added, “The adoption of focused ultrasound is accelerating globally, and we believe it is poised to become the new standard of care across multiple clinical areas.” 

Read the Press Release

Find a Treatment Center

• FUSMobile has announced that its Neurolyser XR system has been granted clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain.
• The device, which uses focused ultrasound to ablate sensory nerves in the spinal facet joints, is also approved in Europe, Canada, and the UK.

FUSMobile has announced that its Neurolyser XR system has been granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of chronic low back pain. This means the FDA has authorized the device as safe and effective, established it as a new category of treatment, and cleared it for marketing in the United States.

The Neurolyser XR is a first-of-its-kind device that uses high-intensity focused ultrasound guided by x-ray fluoroscopy imaging to heat and destroy sensory nerves in the spinal facet joints. These nerves are a leading source of chronic low back pain affecting millions of adults. Clinical data suggest this noninvasive approach could reduce patient discomfort and post-procedure pain compared with traditional interventional methods, such as steroid injections and radiofrequency denervation.

The FDA’s ruling was based on data from the company’s pivotal clinical trial for lumbar zygapophyseal joint syndrome, which took place at 10 sites in the US. These data will be published in the coming months, but similar studies were conducted in Canada and Israel. 

The Neurolyser XR device also has the CE Mark in the European Union, Health Canada approval, and is registered in the UK.

“The FDA’s clearance of the Neurolyser XR represents an important milestone for the field of focused ultrasound,” said Focused Ultrasound Foundation Chairman Neal F. Kassell, MD. “This therapy can deliver better outcomes for patients by providing a safe, highly effective, and cost-effective alternative to existing treatments to countless patients suffering from chronic low back pain.”

According to FUSMobile co-founders Arik Hananel, MD, and Ron Aginsky, “The adoption of focused ultrasound is accelerating globally, and we believe the Neurolyser XR device is poised to become the new standard of care across multiple clinical areas. We take pride in our regulatory approvals and continue to work diligently to advance the Neurolyser platform in other markets while seeking additional clinical indications.”

Looking ahead, the company also has an ongoing clinical trial for the treatment of sacroiliac joint pain and will test the device on patients with chronic knee pain due to osteoarthritis. FUSMobile also plans to explore additional indications in the near future.

The FUSMobile website lists four current treatment centers in Canada, Italy, and Spain.

Dr. Hananel is the former Scientific and Medical Director at the Focused Ultrasound Foundation. He founded FUSMobile in 2014 with Mr. Aginsky to develop noninvasive, high-precision therapies for the treatment of chronic pain.

Read FUSMobile’s Press Release

• The research studies are testing low-intensity focused ultrasound neuromodulation for treating tobacco use disorder, opiate use disorder, and chronic pain. 
• Because they are taking place at the Washington DC VA Medical Center, enrollment is only open to veterans.

Mary Lee, MD, director of the Psychiatric Neuromodulation Service at the US Department of Veterans Affairs (VA) Washington DC VA Medical Center is leading three clinical trials exploring the use of low-intensity focused ultrasound (LIFU) neuromodulation for treating a variety of neuropsychiatric conditions such as tobacco use disorder, opiate use disorder (OUD), and chronic pain.  

Dr. Lee’s team is using the noninvasive Brainbox NeuroFUS device for all three studies, which are currently only open to veterans.  

“The field of focused ultrasound neuromodulation is relatively new, but it may have therapeutic potential for individuals with these types of disorders,” said Dr. Lee. “This is especially important for the veteran population who disproportionately suffer from addiction and chronic pain. We are excited to advance focused ultrasound to develop non-pharmacologic treatments for veterans with addiction and chronic pain.” 

Tobacco Use Disorder 
Smoking remains the leading cause of preventable death in the world, and the total cost of smoking-related illness in the United States is more than $300 billion each year. 

This clinical trial (NCT06405074) examines the effect of LIFU neuromodulation on smoking craving and the brain’s response to smoking cues in individuals who smoke cigarettes. Researchers are targeting a portion of the brain called the dorsal anterior insula, which is associated with smoking craving. Up to 44 participants will be included in the study, and about one-third of those have already been enrolled. The participants receive a single session of LIFU and a single session of sham stimulation – or a simulated procedure where physicians do not actually deliver the focused ultrasound – to the dorsal anterior insula. Dr. Lee and her team are examining the effect of LIFU compared to sham on the brain’s response to smoking cue exposure during functional MRI scanning. In addition, researchers will examine the safety and tolerability of LIFU to this brain region.   

Chronic Pain 
An estimated 100 million Americans have experienced chronic pain, which is associated with an estimated annual cost of $635 billion. Moreover, the most common treatment for chronic pain is pharmaceuticals, which contributed to the opioid use epidemic.  

This clinical trial (NCT06906211) targets the posterior region of the insula that is known to be involved in chronic pain processing. A total of 66 participants with chronic back pain will be enrolled in the trial and will receive one session each of LIFU and sham treatment. Researchers will assess safety and tolerability as well as neural response to evoked pain, clinical pain, and pain intensity symptoms. 

To date, approximately 20 veterans have been enrolled in this study.  

The Complex Patient (Opioid Use Disorder with Chronic Pain and Anxiety) 
This clinical trial (NCT06453109) assesses the safety and tolerability of LIFU for individuals with OUD with co-morbid chronic pain and anxiety. This triad is associated with the highest risk of opiate overdose deaths because co-occurrence of the three disorders amplifies the symptoms of each. 

Dr. Lee and her team are targeting the anterior insula with LIFU to determine its causal role in pain processing, anxiety, and opiate cue–induced craving. The researchers are also assessing the participants’ heart rate variability and pain threshold before and immediately after LIFU compared with sham.  

This trial recently completed enrollment with a total of 20 participants. 

Information for Patients 
The three clinical trials all follow a similar protocol. Participants will have MRI and CT scans during the screening process. If eligible to continue in the study, they will undergo a single session each of noninvasive focused ultrasound and sham. The smoking and chronic pain studies involve fMRI sessions before and after LIFU/Sham sessions.  

The research team completes follow up phone calls with all participants after their study sessions.  

If you are a veteran and are interested in learning more about the two trials that are still seeking participants, please contact: 

Mary R Lee, MD 
202-745-8000, ext. 58128 
mary.lee3@va.gov

• A team at the University of Virginia performed the state’s first focused ultrasound histotripsy procedure for liver tumors.   
• More than 50 medical centers across the US also offer the treatment.  

A team at the University of Virginia (UVA Health) led by Daniel Sheeran, MD, associate professor of radiology and medical imaging, has begun treating patients using HistoSonics’ Edison histotripsy system for liver tumors. The treatments are the first clinical histotripsy procedures in the state.  

Histotripsy noninvasively destroys tissue in the liver by using focused ultrasound to produce controlled acoustic cavitation that mechanically liquifies targeted liver tissue without heating. The procedure was invented by the late Charles A. Cain, PhD, Zhen Xu, PhD, and a team at the University of Michigan.  

In October 2023, histotripsy was cleared by the US Food and Drug Administration, and the Edison system is the first and only such platform available in the US. According to HistoSonics, the system has been adopted at more than 50 medical centers across the US and has been used to treat over 1,500 patients.  

“The UVA Health team is proud to pioneer this noninvasive treatment option for patients in Virginia with liver tumors,” said Dr. Sheeran. “I want to thank the hard work and dedication of many individuals who have made this possible.” 

“The availability of histotripsy in Virginia marks a pivotal step forward for liver cancer care and represents significant progress in expanding the reach of focused ultrasound,” said Neal F. Kassell, MD, founder and chairman of the Focused Ultrasound Foundation. “It’s especially rewarding to see this innovation reaching patients here in our home state, having supported some of the early-stage research that helped establish the feasibility of noninvasive histotripsy for treating liver tumors.” 

Read More from UVA 

For Patients 

If you are interested in learning more about the treatment at UVA, please visit the UVA Health page.  

To find a histotripsy treatment site near you, visit HistoSonics’ patient site.

• Patients with advanced Parkinson’s disease now have the option to receive focused ultrasound on both sides of their brain in two sessions at least six months apart. 
• The treatment for one side was cleared in 2021. 

The US Food and Drug Administration (FDA) will now allow appropriate patients with advanced Parkinson’s disease (PD) to have focused ultrasound treatment – as an adjunct to medication treatment – on the second side of their brain. This ruling is an important milestone for the technology, as PD is a systemic disease with symptoms like rigidity and dyskinesia that can impact the whole body. A noninvasive bilateral treatment option like focused ultrasound will be a good choice for certain patients with advanced PD.

Affecting more than one million people in the US, PD is a neurodegenerative disease that has no cure and often affects both sides of the body. Traditional treatments for motor symptoms include drug therapy and invasive surgery (e.g., deep brain stimulation or radiofrequency lesioning).  

In December 2018, the FDA approved Insightec’s Exablate Neuro focused ultrasound device to treat tremor-dominant PD, which affects approximately 10-20% of the Parkinson’s population. In November 2021, this approval was expanded to include those suffering with mobility, rigidity, or dyskinesia symptoms. For certain patients, focused ultrasound offers a noninvasive alternative to surgery with a lower risk of complications and lower cost. It is important to note that focused ultrasound – and all current therapies – only address the PD symptoms and not the primary disease.  

Now, patients who have undergone focused ultrasound treatment on one side can have the second side treated at least six months after the initial procedure. This second side procedure is also called a staged bilateral treatment. 

The FDA’s decision was based on data from a clinical trial conducted at nine centers across the US, Europe, and Asia that investigated staged bilateral pallidothalamic tractotomy (PTT) in patients with PD and demonstrated encouraging outcomes. Insightec indicates that full results from the study are expected to be published later this year. 

“This is a tremendous milestone for not only the field of focused ultrasound but also patients suffering from this debilitating disease,” said Foundation Chairman Neal F. Kassell, MD. “We congratulate the team at Insightec and all of the investigators, including Daniel Jeanmonod, MD, who successfully pioneered this PTT technique.”  

Read the Insightec Press Release

• The study is testing NaviFUS’s neuronavigation-guided focused ultrasound system for treating patients with drug-resistant epilepsy. 
• Up to 18 participants will be treated in Melbourne. 

A new clinical trial is testing the use of NaviFUS’s neuronavigation-guided focused ultrasound system for the treatment of patients with drug-resistant epilepsy. The study is being led by Professor Terence O’Brien, a specialist in neurology and clinical pharmacology at Alfred Health in Melbourne, Australia.  

Current anti-seizure medications are not effective for all patients with epilepsy, and for those who do not respond to medication, the standard of care is to surgically remove portions of the brain associated with the seizures. However, some patients are not candidates for traditional surgery, which also carries inherent risks (e.g.,  infection).  

The NaviFUS device uses real-time neuronavigation guidance to direct focused ultrasound energy precisely and noninvasively through the skull to select brain tissues without surgery. 

In this research study, up to 18 participants will undergo low-intensity focused ultrasound to generate neuromodulation effects to zones deep in the brain called the hippocampi that are associated with seizures. The goal is to decrease the number of seizures. 

The participants will be divided into two cohorts. The difference between the cohorts is the number of weeks of treatment; the first group will undergo two weeks of treatment, and the second cohort will be treated over three weeks. A safety monitoring committee will review all safety data for Cohort 1 to determine whether it is safe to proceed with Cohort 2. 

The current trial builds on pilot study data published in 2021 that showed no significant adverse events and decreased seizure frequency in a small number of patients. 

“NaviFUS is hopeful that this trial will identify the most effective treatment duration and frequency for patients with drug-resistant epilepsy, ultimately aiming to achieve the optimal therapeutic benefit with the least burden on patients,” said the company’s CEO Arthur Lung, PhD. “For the significant population suffering from drug-resistant epilepsy, this research offers the potential for a noninvasive solution that could be safely administered long-term, providing much-needed relief from seizures and improving their quality of life.” 

For Patients 
Those interested in learning more about this trial are encouraged to contact Caitlin Roberts at +61 3 9076 2598 or cai.roberts@alfred.org.au.

The numbers for 2024 have been tabulated, and we are thrilled to share a landmark achievement for the field: more than ONE MILLION patients have been treated worldwide with focused ultrasound.

The leading treatment indications include uterine fibroids and adenomyosis, essential tremor, Parkinson’s disease, and tumors of the liver, prostate, and pancreas. This incredible milestone reflects the growing recognition of focused ultrasound as a game-changing, noninvasive therapy that is transforming patient care across a wide range of serious conditions. Please note that the treatment numbers are based on reporting from focused ultrasound manufacturers and likely represent a conservative estimate of the actual total number of patients treated.

The Foundation is proud to have played a role in advancing the field, accelerating research, fostering collaboration, and supporting the development of new treatments. But this achievement is a testament to the dedication of researchers, clinicians, industry partners, and supporters like you who have helped move the field forward.

• Natasha Sheybani, PhD, has been awarded a US Department of Defense Breast Cancer Research Program Era of Hope Scholar Award.
• The project includes research, clinical care, and survivorship consultation with cancer survivors, caregivers, and patient advocates.
• This award is follow-on funding from prior Foundation-supported research.

Natasha D. Sheybani, PhD, an assistant professor of biomedical engineering at the University of Virginia (UVA) and research director of the UVA Focused Ultrasound Cancer Immunotherapy Center, was recently notified that she has received an Era of Hope Scholar Award from the US Department of Defense (DOD) Breast Cancer Research Program (BCRP). Sheybani is her institution’s first recipient of this award and the only Era of Hope Scholar being named nationwide for fiscal year 2024.

According to the Department of the Army, this prestigious award is given to “exceptionally talented scientists who have shown that they are the ‘best and brightest’ in their field(s) through extraordinary creativity, vision, innovation, and productivity. They should have demonstrated experience in forming effective partnerships and collaborations and must exhibit strong potential for future leadership in breast cancer research.”

The $5.5 million grant will catalyze the Sheybani Lab’s development of focused ultrasound technology solutions to improve the safety, effectiveness, and precision of immunotherapy drugs in patients with breast cancer.

Beyond advancing cancer immunotherapy research, this funding will also be used to support a new infrastructure for bringing cancer survivors, caregivers, and patient advocates together with cancer clinicians, researchers, and trainees to hold critical conversations on the topics of cancer research, clinical care, and survivorship. This patient-centered aspect of the project will be accomplished in collaboration with UVA’s NCI-designated Comprehensive Cancer Center.

“We are so grateful for the support of this transformative mechanism. This investment will catalyze our efforts to fortify focused ultrasound technology as a mainstay in the treatment of primary breast tumors and breast cancers that have spread to the brain,” said Dr. Sheybani. “This award is a tremendous vote of confidence in our bold vision for focused ultrasound immuno-oncology here at UVA and beyond, and it reinforces our lab’s commitment to advancing this field.”

“Having served on the parent committee of the DOD BCRP for the last two years, I can say unequivocally that the Era of Hope Award is one of the most prestigious of all of the awards in the Program’s portfolio,” said Amy Bouton, PhD, Harrison Distinguished Teaching Professor Emerita of Microbiology, Immunology and Cancer and inaugural Associate Director (2014-2023) for Education and Training in the Cancer Center at UVA. “In receiving this award, Dr. Sheybani has not only solidified her position as a rising star in the breast cancer research field, but she also brings significant distinction to UVA and the Comprehensive Cancer Center.”

This award is follow-on funding from prior Foundation-supported research and serves to further strengthen the impactful translational work underway at UVA’s Focused Ultrasound Cancer Immunotherapy Center. The Foundation congratulates Dr. Sheybani on this impressive and highly impactful project!

• The founder of the White House Writers Group lived with essential tremor since childhood. 
• In 2022, he underwent focused ultrasound treatment and calls the experience “extraordinary.”

Clark Judge is the founder and CEO of the White House Writers Group, a strategic communications and public affairs firm based in Washington, DC. Clark has advised some of the world’s most prominent corporations and served as speechwriter and special assistant to both President Ronald Reagan and Vice President George Bush. 

As far back as he can remember, Clark has lived with essential tremor, a common neurological condition that causes involuntary and rhythmic shaking that generally affects the hands.  

“The essential tremor was first called to my attention by my family doctor in the early 90s, but I can remember parts of my childhood that were impacted by it. When I was about 10 years old, I went to summer camp, and – as was common at that time – marksmanship was one of the activities. I could never keep the rifle barrel steady. My shot always wandered.” 

As he grew up, Clark ignored the tremor as nothing more than a nuisance. It wasn’t until he was well into his adult years that it began to impact daily life.  

“It was difficult to sign my name, and I gradually abandoned taking notes. I spilled drinks at dinner, and if I had to stand in front of an audience, I would put my hands in my pockets. Shortly before the pandemic, I was part of a panel at a large event in Rome. We were sitting in chairs on the stage and the microphone was being passed around. I knew I couldn’t hold my notes or the microphone without distracting the audience. I ended up holding the microphone with both hands and leaning forward with my elbows on my knees. It may have seemed a little awkward, but I got through it.” 

As the tremors began to infiltrate his work and life, Clark tried medications to still his hands, but he found they were only effective for a brief time. Then, he learned of another option.  

“I knew of focused ultrasound almost as soon as it was FDA approved. A friend had attended a lecture at the University of Virginia and told me I really had to try it. I was intrigued, but I didn’t pursue it further at that time.” 

But a few years later, at the insistence of one of his clients, Clark took a meeting with Foundation Chairman Neal F. Kassell, MD. That discussion led to a consultation with physicians at the University of Maryland.  

“They reviewed all of the treatment options with me. I already knew medications were not working, and I thought deep brain stimulation seemed like overkill. It involved drilling a hole in the brain and then inserting a wire that was going to be there for the rest of your life. In my view, that had all sorts of dangers that were way beyond anything that I thought was appropriate given the condition. Ultimately, focused ultrasound had all the qualities I wanted in a treatment; it was a long-term solution that would be noninvasive and make my hand usable again in daily life.” 

Clark reports that during the treatment, he didn’t feel anything and was very relaxed. He simply laid with his eyes closed – albeit in an MRI machine.  

“It was not something that I would even characterize as in the category of surgery, except of course it was. It changed something physical inside my brain that repaired something physical on my hand. It worked exactly as I’d expected. I walked over to meet my wife for lunch afterward.” 

Now, three years later, Clark is happy to report that focused ultrasound has taken away dozens of barriers that the tremors created in his life.  

“I don’t worry about my hands shaking and distracting people in meetings or on a stage. I can go to a dinner and maneuver the utensils, drink without spilling, and eat soup. Also, since writing is a large part of what I do, being able to write with a pen is a big deal. I couldn’t do that for a really long time.”

“Focused ultrasound is a remarkable therapy – as, of course, are most therapies these days – but this is in a category by itself. There are few treatments that cause little to no unwanted impact on the patient, require no recovery time, and work so quickly and effectively. It is extraordinary. This technology is likely one of the great unsung advances in medicine of the last half century.”