More than one million patients worldwide had been treated with focused ultrasound by April 2025, and over 150,000 of them in 2024 alone (Focused Ultrasound Foundation, press release April 2025). The largest published focal HIFU registry for prostate cancer reports a 7-year failure-free survival of 69% (Reddy et al., European Urology 2022). In the brain, the pivotal essential tremor trial cut hand tremor scores from 18.1 to 9.6 points against almost no change after a sham procedure (Elias et al., New England Journal of Medicine 2016). We aggregated data from the Focused Ultrasound Foundation, the US FDA premarket approval, De Novo and 510(k) databases, European Urology, The Lancet Oncology, The New England Journal of Medicine, and peer-reviewed reviews of acoustic physics. This roundup covers therapeutic ultrasound only; for the imaging-probe side of the business, see our medical ultrasound transducer market statistics. Nothing here is medical advice: the figures describe what studies and registries reported, with their limitations.
TL;DR
- More than 1,000,000 patients treated with focused ultrasound worldwide by April 2025 (Focused Ultrasound Foundation, press release April 2025).
- 1,203 commercial focused ultrasound treatment sites and 1,642 installed devices worldwide at the end of 2023 (Focused Ultrasound Foundation, State of the Field Report 2024).
- 13 FDA records under the prostate HIFU product code PLP, from 4 applicants, between 2015 and 2025 (openFDA 510(k) database, product code PLP).
- 8.9% (95% CI 6.2-12.5%) pooled rate of clinically significant cancer found inside the treated zone after focal therapy (Tay et al., Prostate Cancer and Prostatic Diseases 2025).
- 69% (95% CI 64-74%) 7-year failure-free survival after focal HIFU in 1,379 men (Reddy et al., European Urology 2022).
- 88% (95% CI 79-94%) of men had no grade group 2 or higher cancer in the treated zone 24 months after MRI-guided focused ultrasound (Ehdaie et al., Lancet Oncology 2022).
- Pooled standardized mean difference of -1.91 in tremor after staged treatment of both brain sides, across 7 cohorts and 149 patients (Sherpa et al., Movement Disorders Clinical Practice 2026).
- 29% vs 44%: 12-month continence deterioration after HIFU vs radical prostatectomy (HIFI trial, European Urology 2025).
- 69% vs 32% responders after focused ultrasound pallidotomy vs sham in Parkinson’s disease (Krishna et al., NEJM 2023).
- 51.9% improvement in tremor and motor scores still present 5 years after unilateral thalamotomy (Ghanouni et al., Frontiers in Neurology 2025).
- 100-10,000 W/cm2 spatial-average intensity range for focused ultrasound surgery (Kim et al., Korean Journal of Radiology 2008).
1. Global Footprint: Patients, Indications, and Treatment Sites
The million-patient mark is a milestone, but the annual pace matters more: over 150,000 patients were treated in 2024 alone, against a cumulative total that had only just passed one million. Uterine fibroids remain the volume leader, and liver tumours rank second with over 175,000 patients at 122 sites (Focused Ultrasound Foundation, press release April 2025). The pipeline is far wider than the approved list: more than 180 conditions are in research, against 34 approved indications, which means most of the field is still experimental.
The site count tells the same story from the supply side. The Foundation’s 2024 report counted 245 commercial sites in the United States, 88 in France and about half of all sites in Asia, led by China, and it recorded more than 141,000 new treatments in 2023, up 44% on the prior report, partly because a major manufacturer reported data for the first time in recent years (Focused Ultrasound Foundation, State of the Field Report 2024). Research is moving into new territory too: a 2026 review counted 34 registered clinical trials of focused ultrasound for brain tumours, 18 of them completed (Heidar et al., Cancers 2026).
| Metric | Value | Source |
|---|---|---|
| Cumulative patients treated with focused ultrasound worldwide (commercial plus clinical trial) | More than 1,000,000 | Focused Ultrasound Foundation, press release April 2025 |
| Indications with regulatory approval somewhere in the world | 34 | Focused Ultrasound Foundation, press release April 2025 |
| Diseases and conditions in research and development | Over 180 | Focused Ultrasound Foundation, press release April 2025 |
| Uterine fibroid patients treated and sites offering it | Nearly 379,000 patients at 535 sites | Focused Ultrasound Foundation, press release April 2025 |
| Commercial focused ultrasound treatment sites worldwide, end of 2023 | 1,203 | Focused Ultrasound Foundation, State of the Field Report 2024 |
| Focused ultrasound devices installed at sites worldwide, end of 2023 | 1,642 | Focused Ultrasound Foundation, State of the Field Report 2024 |
| Indications identified in total, end of 2023 (all stages) | 171 | Focused Ultrasound Foundation, State of the Field Report 2024 |
| Registered clinical trials of focused ultrasound for brain tumours on ClinicalTrials.gov, June 2026 (completed / ongoing) | 34 (18 / 16) | Heidar et al., Cancers 2026 |
Most recent available data for site and device counts: Focused Ultrasound Foundation, State of the Field Report 2024 (2023 data). A 2026 edition with cumulative data through December 31, 2025 has been published as an interactive State of the Field platform, but its figures sit in charts we could not read as text, so they are not used here.
2. The US Regulatory Record: PMAs, De Novo, and 510(k) Clearances
US access has arrived in two very different lanes. Brain, fibroid and bone applications went through premarket approval (PMA), the FDA’s strictest pathway for high-risk devices, while prostate HIFU entered through a De Novo request (a route for new low-to-moderate-risk devices with no predicate) and then expanded through 510(k) clearances, which only require showing equivalence to an existing device. The prostate product code PLP now holds 13 records from 4 applicants, which is a crowded field for a device type that did not exist in FDA classification before October 2015.
The Exablate Neuro PMA shows how indications grow after a first approval: the 2016 essential tremor approval has accumulated 42 supplements, including an essential tremor labeling change approved on December 8, 2022 (FDA PMA database, P150038). The 2025 supplement allows a staged second procedure on the other side of the brain at least 6 months after the first, for patients aged 30 or older (FDA PMA database, P150038/S037). Separately, histotripsy, a non-thermal form of focused ultrasound that breaks tissue apart mechanically, received FDA clearance in October 2023 as the first nonthermal ablation mechanism approved (Focused Ultrasound Foundation, State of the Field Report 2024).
| Metric | Value | Source |
|---|---|---|
| First FDA PMA for MR-guided focused ultrasound (P040003, uterine fibroid ablation) | October 22, 2004 | FDA PMA database (openFDA), P040003 |
| PMA for pain palliation of bone metastases (P110039) | October 18, 2012 | FDA PMA database (openFDA), P110039 |
| PMA for unilateral thalamotomy in medication-refractory essential tremor, patients aged 22 or older (P150038) | July 11, 2016 | FDA PMA database, P150038 |
| Supplement adding tremor-dominant Parkinson’s disease, patients aged 30 or older (S006) | December 16, 2018 | FDA PMA database, P150038/S006 |
| Supplement adding unilateral pallidotomy for advanced Parkinson’s disease with motor complications (S014) | October 29, 2021 | FDA PMA database, P150038/S014 |
| Supplement allowing a staged procedure on the second side of the brain in Parkinson’s disease (S037) | July 3, 2025 | FDA PMA database, P150038/S037 |
| De Novo grant creating the device type ‘high intensity ultrasound system for prostate tissue ablation’ (Sonablate 450, DEN150011) | October 9, 2015 | FDA De Novo database, DEN150011 |
| FDA records under prostate HIFU product code PLP (1 De Novo plus 12 510(k) clearances), 2015 to 2025 | 13 records from 4 applicants | openFDA 510(k) database, product code PLP |
Context: the 13 PLP records come from SonaCare Medical, Profound Medical, EDAP Technomed and Insightec (openFDA 510(k) database, product code PLP). The regulation number for the device type is 876.4340 (FDA De Novo database, DEN150011). openFDA warns that its data are unvalidated and not for clinical decisions.
3. Prostate Cancer Focal Therapy: Cancer Control Outcomes
Focal therapy treats only the tumour-bearing part of the prostate instead of removing the whole gland. The headline number from the largest registry, 69% failure-free survival at 7 years in 1,379 men, has to be read with its definition in mind: ‘failure-free survival’ is a composite endpoint, and each study defines what counts as failure. In that registry, 252 men had a repeat focal treatment and 92 needed salvage whole-gland therapy, and only 325 men (24%) had 5 or more years of follow-up (Reddy et al., European Urology 2022).
The near-identical results across risk groups (68% intermediate, 65% high risk, p = 0.3) are the more surprising finding, though the authors note the 10-year median follow-up is not yet available. The French HIFI trial, the largest comparison with surgery, enrolled 3,328 men at 46 centres; HIFU patients were older (median 74.7 vs 65.1 years), and the trial was not randomized (HIFI trial, European Urology 2025). Grade group (GG) 2 or higher means clinically significant cancer on the Gleason-based grading scale.
| Metric | Value | Source |
|---|---|---|
| 7-year failure-free survival after focal HIFU, all 1,379 men (13 UK centres, 2005 to 2020) | 69% (95% CI 64-74%) | Reddy et al., European Urology 2022 |
| 7-year failure-free survival, intermediate-risk vs high-risk disease | 68% (95% CI 62-75%) vs 65% (95% CI 56-74%), p = 0.3 | Reddy et al., European Urology 2022 |
| Men needing a repeat focal treatment vs a salvage whole-gland treatment | 252 vs 92 | Reddy et al., European Urology 2022 |
| Men with no GG 2 or higher cancer in the treated area 24 months after MRI-guided focused ultrasound (8 US centres) | 78/89 (88%; 95% CI 79-94%) | Ehdaie et al., Lancet Oncology 2022 |
| Radical or systemic treatment-free survival after focal HIFU with prostate compression, low / intermediate / high D’Amico risk (n = 240, median follow-up 48 months) | 96.1% / 94.4% / 95.1% | Shoji et al., Prostate Cancer and Prostatic Diseases 2025 |
| Pooled composite failure across 49 focal therapy cohorts (21 cryotherapy, 20 HIFU, 8 irreversible electroporation) | 14.1% (95% CI 10.2-19.2%) | Tay et al., Prostate Cancer and Prostatic Diseases 2025 |
| Pooled in-field clinically significant cancer (GG 2 or higher) on biopsy after focal therapy | 8.9% (95% CI 6.2-12.5%) | Tay et al., Prostate Cancer and Prostatic Diseases 2025 |
| 30-month salvage therapy-free survival, whole-gland or subtotal HIFU vs radical prostatectomy (3,328 men, nonrandomized) | Hazard ratio 0.71 (95% confidence interval 0.52-0.97; p = 0.008) for noninferiority | HIFI trial, European Urology 2025 |
Outlier note: the meta-analysis found no differences between cryotherapy, HIFU and irreversible electroporation in any outcome (Tay et al., Prostate Cancer and Prostatic Diseases 2025), so the pooled figures above describe focal therapy as a category, not HIFU alone.
4. Prostate HIFU: Continence, Erectile Function, and Complications
The case for focal therapy rests less on cancer control than on side effects, and this is where the numbers diverge most from surgery. In the HIFI trial, 12-month urinary continence deteriorated in 29% of HIFU patients vs 44% after radical prostatectomy, and the median IIEF-5 erectile function score fell by 7 points instead of 13 (HIFI trial, European Urology 2025). HIFU is not free of urinary cost: about 10% of HIFU patients in the same trial had urinary retention (inability to empty the bladder).
In the US phase 2b trial, no man reported stress incontinence needing pads, no serious treatment-related adverse events were reported and only one adverse event exceeded grade 2, a grade 3 urinary tract infection (Ehdaie et al., Lancet Oncology 2022). Across 34 focal therapy cohorts reporting urinary function, 97.1% reported a low impact (Tay et al., Prostate Cancer and Prostatic Diseases 2025).
| Metric | Value | Source |
|---|---|---|
| Patients with a Clavien-Dindo complication above grade 2 (needing a surgical, endoscopic or radiological intervention, or worse) after focal HIFU | 0.5% (7/1,379) | Reddy et al., European Urology 2022 |
| Men who were continent before treatment with an ICIQ-UI incontinence score below 10 at 24 months | 100% (reported probability) | Ehdaie et al., Lancet Oncology 2022 |
| Change in erectile function score at 24 months vs baseline after MRI-guided focused ultrasound | Mean difference -3.5 (95% CI -5.4 to -1.6), statistically but not clinically significant per authors | Ehdaie et al., Lancet Oncology 2022 |
| Deterioration in 12-month urinary continence, HIFU vs radical prostatectomy | 29% vs 44% | HIFI trial, European Urology 2025 |
| Decrease in median IIEF-5 erectile function score, HIFU vs radical prostatectomy | -7 vs -13 points | HIFI trial, European Urology 2025 |
| Complications above grade IIIa, HIFU vs radical prostatectomy | 54/1,967 vs 29/1,361 (p = 0.3) | HIFI trial, European Urology 2025 |
| Share of 35 focal therapy studies reporting a low / moderate / severe impact on sexual function | 45.7% / 48.6% / 5.7% | Tay et al., Prostate Cancer and Prostatic Diseases 2025 |
| Urethral stricture (CTCAE grade 2) vs recto-urethral fistula after focal HIFU with prostate compression | 2.9% vs 0% | Shoji et al., Prostate Cancer and Prostatic Diseases 2025 |
Context: in the Japanese multicentre study, urinary and sexual function scores worsened at 1 month but returned to preoperative levels at 3 or 6 months (Shoji et al., Prostate Cancer and Prostatic Diseases 2025). Functional questionnaires differ between studies, so these rows are not directly comparable with each other.
5. Brain Applications: Essential Tremor and Parkinson’s Disease Trials
Brain treatments are a small slice of total volume but the fastest-moving one: 30% of all cumulative brain treatments took place in 2023, and 96% of those were for essential tremor or Parkinson’s disease (Focused Ultrasound Foundation, State of the Field Report 2024). The procedures here are thalamotomy (a small thermal lesion in the thalamus, the brain’s relay for tremor signals) and pallidotomy (a lesion in the globus pallidus, used for Parkinson’s motor complications), both made through the intact skull. The pivotal essential tremor trial produced a between-group difference of 8.3 points (95% CI, 5.9 to 10.7; P<0.001) in hand tremor scores at 3 months against a sham procedure (a placebo procedure without energy delivery) (Elias et al., NEJM 2016).
Durability is the real question for a one-time lesion. Five years after unilateral treatment, tremor severity was still 67.4% better than baseline, but functional disability scores improved by only 35.4%, down from 65.4% at 1 year, and just 26 of 61 patients (42.6%) were followed for the full 5 years (Ghanouni et al., Frontiers in Neurology 2025). In Parkinson’s pallidotomy, 30 of 39 responders assessed at 12 months were still responding (Krishna et al., NEJM 2023). For the speech side of Parkinson’s care, see our Parkinson’s speech and voice treatment statistics.
| Metric | Value | Source |
|---|---|---|
| Hand tremor score, thalamotomy vs sham, baseline to 3 months (76 patients, 3:1 randomization) | 18.1 to 9.6 points vs 16.0 to 15.8 points | Elias et al., NEJM 2016 |
| Gait disturbance and paresthesias (numbness or tingling) after thalamotomy, overall vs still present at 12 months | 36% and 38% overall; 9% and 14% still present at 12 months | Elias et al., NEJM 2016 |
| Improvement in tremor and motor function (CRST A+B) from baseline, at 1 year vs at 5 years | 62.2% vs 51.9% | Ghanouni et al., Frontiers in Neurology 2025 |
| Improvement in quality of life (QUEST) from baseline, at 1 year vs at 5 years | 53.6% vs 43.7% | Ghanouni et al., Frontiers in Neurology 2025 |
| Share of 121 treatment-related adverse events rated mild / moderate / severe | 85.1% / 11.6% / 3.3% | Ghanouni et al., Frontiers in Neurology 2025 |
| Pooled tremor reduction after staged treatment of both sides (7 cohorts, n = 149), standardized mean difference | -1.91 (95% confidence intervals, -2.19 to -1.63; I2 = 0%) | Sherpa et al., Movement Disorders Clinical Practice 2026 |
| Parkinson’s patients responding 3 months after pallidotomy vs sham | 45/65 (69%) vs 7/22 (32%); difference 37 points (95% CI, 15 to 60; P = 0.003) | Krishna et al., NEJM 2023 |
| Parkinson’s patients with at least 30% tremor reduction 6 months after thalamotomy (single-centre cohort of 107) | 52/92 (56.5%) | Pistoia et al., Journal of Neurology 2026 |
Caveat: the staged bilateral meta-analysis pooled only single-arm, non-randomized studies, rated the certainty of evidence very low, and reported 3-month sensory changes in 28.8% and gait disturbance in 27.5% of patients (Sherpa et al., Movement Disorders Clinical Practice 2026). In the Parkinson’s cohort, response at 24 hours (85/98, 86.7%) faded to 56.5% by 6 months (Pistoia et al., Journal of Neurology 2026). For a different noninvasive brain-adjacent comparison, our vestibular schwannoma treatment statistics cover radiosurgery outcomes.
6. Acoustic Parameters: Intensities, Temperatures, and Focal Size
The physics explains why HIFU can ablate a target without an incision: energy that does little as it crosses skin and tissue converges on a single lesion measuring about 1.5-2 mm in width and about 1.5-2 cm in length (Kim et al., Korean Journal of Radiology 2008). Focused ultrasound surgery uses spatial-average intensities of 100 to 10,000 W/cm2, against a cutoff of just 5 W/cm2 that defines ‘high-intensity’ ultrasound in the first place (Kim et al., Korean Journal of Radiology 2008). The clinical spread is wide: one clinical study (Wu, 2003) listed in a 2017 review used 5,000 to 15,000 W/cm2 at 1.6 MHz (van den Bijgaart et al., Cancer Immunology, Immunotherapy 2017), while prostate devices are often set by electrical power, for example 20 W to 48 W adjusted during treatment (Shoji et al., Prostate Cancer and Prostatic Diseases 2025).
The sharpness of the lesion edge is the most striking detail: the boundary between necrotic and normal tissue is no more than 50 µm, a fraction of a millimetre (Izadifar et al., Journal of Clinical Medicine 2020). The transcranial Exablate helmet uses a 1,024-element phased array to steer energy through the skull, and the histotripsy bubble cloud measures about 3 x 3 x 6 mm (Heidar et al., Cancers 2026). Our acoustic levitation and ultrasonic particle manipulation statistics cover the low-power end of the same physics.
| Metric | Value | Source |
|---|---|---|
| Spatial-average intensity range used in focused ultrasound surgery | 100-10,000 W/cm2 | Kim et al., Korean Journal of Radiology 2008 |
| Temperature and time for protein coagulation (coagulation necrosis) | 56 degrees C for 1 second | Kim et al., Korean Journal of Radiology 2008 |
| Temperature rise causing immediate, irreversible cell death | More than 60 degrees C lasting longer than 1 second | Izadifar et al., Journal of Clinical Medicine 2020 |
| Focal zone temperature reached by thermal HIFU | 60-85 degrees C in a few seconds | van den Bijgaart et al., Cancer Immunology, Immunotherapy 2017 |
| Target temperature during MRI-guided prostate ablation (median 15 sonications per patient) | Approximately 60-70 degrees C | Ehdaie et al., Lancet Oncology 2022 |
| Width and length of the -6 dB focal beam (the zone where the beam stays within 6 decibels of its peak) | Typically 1-3 mm wide, approximately 10 mm long | Izadifar et al., Journal of Clinical Medicine 2020 |
| Operating frequencies, deep and transcranial targets vs superficial targets | As low as 0.5 MHz vs up to 8 MHz | Izadifar et al., Journal of Clinical Medicine 2020 |
| Peak positive / negative pressure in preclinical (mouse tumour) mechanical HIFU studies at 3.3 MHz, 2% duty cycle | 31.7 MPa / 12.5 MPa | van den Bijgaart et al., Cancer Immunology, Immunotherapy 2017 |
Most recent available data for physics reference values: Kim et al. 2008, van den Bijgaart et al. 2017 and Izadifar et al. 2020. These values describe the physics and are stable over time, but device-specific settings vary. Clinical histotripsy data are newer: a 2026 meta-analysis of 10 studies and 553 liver tumour patients reported a pooled technical success rate of 94.1% (95% CI: 90.4%-96.4%) and pooled major complications of 7.0% (95% CI: 2.0%-21.5%) (Histotripsy for liver tumours meta-analysis, eClinicalMedicine 2026).
Summary: High-Intensity Focused Ultrasound by the Numbers
| Metric | Value | Source |
|---|---|---|
| Cumulative patients treated with focused ultrasound worldwide | More than 1,000,000 | Focused Ultrasound Foundation, press release April 2025 |
| Commercial treatment sites worldwide, end of 2023 | 1,203 | Focused Ultrasound Foundation, State of the Field Report 2024 |
| FDA PMA for essential tremor thalamotomy | July 11, 2016 | FDA PMA database, P150038 |
| De Novo grant for prostate tissue ablation by HIFU | October 9, 2015 | FDA De Novo database, DEN150011 |
| FDA records under prostate HIFU product code PLP | 13 from 4 applicants | openFDA 510(k) database, product code PLP |
| 7-year failure-free survival after focal HIFU (1,379 men) | 69% (95% CI 64-74%) | Reddy et al., European Urology 2022 |
| No GG 2 or higher cancer in treated area at 24 months | 78/89 (88%; 95% CI 79-94%) | Ehdaie et al., Lancet Oncology 2022 |
| Pooled in-field clinically significant cancer after focal therapy | 8.9% (95% CI 6.2-12.5%) | Tay et al., Prostate Cancer and Prostatic Diseases 2025 |
| Clavien-Dindo complication above grade 2 after focal HIFU | 0.5% (7/1,379) | Reddy et al., European Urology 2022 |
| 12-month continence deterioration, HIFU vs radical prostatectomy | 29% vs 44% | HIFI trial, European Urology 2025 |
| Median IIEF-5 decrease, HIFU vs radical prostatectomy | -7 vs -13 points | HIFI trial, European Urology 2025 |
| Hand tremor score, thalamotomy vs sham (baseline to 3 months) | 18.1 to 9.6 vs 16.0 to 15.8 points | Elias et al., NEJM 2016 |
| Tremor and motor improvement 5 years after unilateral thalamotomy | 51.9% | Ghanouni et al., Frontiers in Neurology 2025 |
| Parkinson’s responders, pallidotomy vs sham | 69% vs 32% | Krishna et al., NEJM 2023 |
| Pooled tremor reduction after staged treatment of both brain sides (standardized mean difference) | -1.91 (95% confidence intervals, -2.19 to -1.63) | Sherpa et al., Movement Disorders Clinical Practice 2026 |
| Pooled technical success of histotripsy for liver tumours (10 studies, 553 patients) | 94.1% (95% CI: 90.4%-96.4%) | Histotripsy for liver tumours meta-analysis, eClinicalMedicine 2026 |
| Intensity range in focused ultrasound surgery | 100-10,000 W/cm2 | Kim et al., Korean Journal of Radiology 2008 |
| Thermal HIFU focal temperature | 60-85 degrees C in a few seconds | van den Bijgaart et al., Cancer Immunology, Immunotherapy 2017 |
Methodology and Sources
- Focused Ultrasound Foundation, State of the Field Report 2024 newsletter summary (2023 data): patients, devices, sites, indications, approvals.
- Focused Ultrasound Foundation, press release ‘Focused ultrasound exceeds one million patients treated worldwide’, April 2025, distributed via Newswise.
- Focused Ultrasound Foundation, State of the Field 2026 landing page (interactive edition, data through December 31, 2025).
- US FDA, PMA database record P150038 and supplement S037; supplements S006, S014 and S022 read on the same database.
- US FDA via openFDA, PMA records for P150038 and original Insightec PMAs (P040003, P110039, P150038).
- US FDA, De Novo database record DEN150011 and openFDA 510(k) records for product code PLP.
- Reddy et al., Cancer Control Outcomes Following Focal Therapy Using HIFU in 1379 Men, European Urology 2022.
- Ehdaie et al., MRI-guided focused ultrasound focal therapy for intermediate-risk prostate cancer, Lancet Oncology 2022.
- Shoji et al., Focal HIFU with intraoperative prostate compression, Prostate Cancer and Prostatic Diseases 2025.
- Tay et al., Established focal therapy (HIFU, IRE, cryotherapy) systematic review and meta-analysis, Prostate Cancer and Prostatic Diseases 2025.
- HIFI trial, Whole-gland or Subtotal HIFU Versus Radical Prostatectomy, European Urology 2025.
- Elias et al., A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor, NEJM 2016.
- Ghanouni et al., Unilateral MRgFUS for essential tremor: 5-year continued access study, Frontiers in Neurology 2025.
- Sherpa et al., Staged bilateral MRgFUS for essential tremor: systematic review and meta-analysis, Movement Disorders Clinical Practice 2026.
- Krishna et al., Trial of Globus Pallidus Focused Ultrasound Ablation in Parkinson’s Disease, NEJM 2023.
- Pistoia et al., Clinical outcomes at 6 months after MRgFUS thalamotomy in Parkinson’s disease, Journal of Neurology 2026.
- Kim et al., High-intensity focused ultrasound therapy: an overview for radiologists, Korean Journal of Radiology 2008.
- van den Bijgaart et al., Thermal and mechanical HIFU for tumor ablation, Cancer Immunology, Immunotherapy 2017.
- Izadifar et al., An Introduction to High Intensity Focused Ultrasound, Journal of Clinical Medicine 2020.
- Heidar et al., Focused Ultrasound Therapies for Brain, Liver, Prostate, and Breast Cancer Applications, Cancers 2026.
- Histotripsy for liver tumours: systematic review and meta-analysis, eClinicalMedicine 2026.
- Data watch: the per-condition patient and site counts in the Focused Ultrasound Foundation’s April 2025 release come from manufacturer data, and the 44% jump in 2023 treatments was partly caused by a manufacturer reporting for the first time, so year-over-year growth is not a clean trend. The 34 approved indications (April 2025 release) and the 31 indications approved by at least one regulator (2024 report) refer to different data years, not a conflict. The State of the Field 2026 edition (data through December 31, 2025) exists only as interactive charts we could not read, so newer site and device totals are expected there. The 2026 Cancers review reports HIFI trial figures (hazard ratio 0.76, IIEF-5 change -4 vs -9) that differ from the trial’s own abstract (hazard ratio 0.71, -7 vs -13); we use the primary publication. The Shoji et al. abstract and its Table 2 assign biochemical and pathological disease-free survival values inconsistently, so we report only its treatment-free survival. The eClinicalMedicine histotripsy meta-analysis gives 7.0% major complications in its abstract and 5.6% (95% CI: 1.3%-21.3%) in its Table 3. None of the prostate cohorts except the HIFI comparison has a surgical control arm, and HIFI was not randomized. Reddy et al. 2022, Ehdaie et al. 2022, Elias et al. 2016 and the physics reviews are older than 3 years: most recent available data for those specific endpoints.
Last updated: October 24, 2026. We update this roundup quarterly, and the next refresh is expected when the Focused Ultrasound Foundation publishes its next Year in Review and State of the Field figures covering 2025 in a readable report.