Focused ultrasound is cleared to treat liver tumors in the United States.
The US Food and Drug Administration (FDA) has cleared HistoSonics’ novel therapy platform – called EdisonTM – to treat liver tumors. EdisonTM uses histotripsy to noninvasively destroy tissue in the liver and is the first and only such platform available in the US. This is also the first time the use of histotripsy has earned regulatory approval worldwide. Read More
Focused Ultrasound Therapy
Focused ultrasound is a rapidly evolving, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with liver tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated.
One mechanism is the production of precise ablation (thermal destruction of tissue). This destruction can be done to completely destroy the target or to partially treat it, and partial treatment is believed to stimulate the patient’s immune response, which may have a broader impact.
Another mechanism is the use of mechanical (non-thermal) histotripsy to destroy the tumor.
A third mechanism is to use focused ultrasound to cause hyperthermia which enables the local release and absorption of a therapeutic that is contained in the blood stream.
A fourth mechanism is to use Boiling Histotripsy to destroy the targets in the liver. This has the advantage that it may be useful as a ‘bridging’ technique to treat the patient and may also help in the regrowth of non-fibrous tissue, as the patient is waiting for a liver transplant. While this has had success in animal models, it has not yet been transferred to human treatment.
Advantages
The primary options for treatment of liver tumors include surgery, chemotherapy, radiotherapy, localized destruction of the tumor tissue (via radiofrequency ablation, alcohol injection, cryosurgery, or laser photocoagulation), or combination of two or more of these options. The long-term solution for primary liver cancer is often liver transplantation.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. Focused ultrasound can also enhance the chemotherapy dose for the target, with less impact to the rest of the patient.
Clinical Trials
A clinical trial in Singapore will be using the Histosonics system to ablate liver tumors in patients with both primary and secondary liver disease.
A clinical trial in the UK is recruiting patients with colorectal cancer and metastasis to the liver. It uses focused ultrasound to activate a microbubble preparation designed to improve the penetration of chemotherapy to the liver.
An observational clinical trial is being done on patients treated with the Histosonics’ Edison device looking for long term outcomes for the patients treated.
A clinical trial is treating colorectal cancer metastasis with to the liver with the Histosonic’s Edison device in Ohio.
A clinical trial registry is treating patients at UCSF, and looking at the use of histotripsy for outcomes measurements after standard clinical use of this procedure.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
See a list of treatment sites >
See a list of laboratory research sites >
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Regulatory Approval and Reimbursement
In October 2023, the US Food and Drug Administration cleared HistoSonics’ Edison device to noninvasively treat liver tumors using histotripsy.
A focused ultrasound system has been approved in China, Russia, Europe, and Korea for treatment of liver cancer.
To the best of our knowledge, the use of focused ultrasound to treat liver cancer is not yet widely reimbursed by medical insurance.
Notable Papers
Yang F, Li B, Huang G, Luo W, Zhang J, Liu L, Yang W, Li N. Construction and validation of a prognostic model for 1 year all-cause mortality risk in patients with colorectal cancer liver metastases after HIFU treatment. Clin Transl Oncol. 2026 Mar 24. doi: 10.1007/s12094-026-04327-3. PMID: 41874948
Centner CS, Choi R, Georgiades CS, Yarchoan M, Weiss CR. Thermal and Nonthermal Liver Ablation: Mechanistic Foundations, Clinical Implementation, Immunologic Trial Design, and Artificial Intelligence. Radiology. 2026 Mar;318(3):e250263. doi: 10.1148/radiol.250263. PMID: 41874295
Falk KL, Speidel MA, Minesinger GM, Foltz GM, Lee FT Jr, Ziemlewicz TJ, Wagner MG, Laeseke PF. Injectable radiopaque targets for cone-beam CT guided histotripsy. Int J Hyperthermia. 2026 Dec;43(1):2642172. doi: 10.1080/02656736.2026.2642172. Epub 2026 Mar 12. PMID: 41821321
Ng HHL, Chan VW, Howell L, Shiwani T, Zhong J, Brandon J, Samson A, Chandler J, Mclaughlan J, Wah TM. Early Adoption of Image-Guided Histotripsy Therapy in Interventional Oncology: Challenges and Opportunities in the UK. Br J Radiol. 2026 Mar 12:tqag047. doi: 10.1093/bjr/tqag047. PMID: 41818689
Gu K, Rhim H, Lee MW, Han S. Ultrasound-guided ablation of hepatocellular carcinoma: a review of its past, present, and future. Ultrasonography. 2026 Mar;45(2):95-106. doi: 10.14366/usg.25264. Epub 2026 Feb 27. PMID: 41802321
Zhang B, Iqbal MS, Yan Y, Wang H, Wang X, Zhang Y, Guo B. Next-generation dynamic and combinatorial nanotherapies for liver cancer: mechanisms, current advances and future perspectives. J Nanobiotechnology. 2026 Feb 7. doi: 10.1186/s12951-026-04102-0. PMID: 41654811
Breuer JA, Mendiratta-Lala M, Lee FT Jr, Lalani Z, Poe L, Caoili EM, Imagawa DK, Chiang J, Raman SS, Hinshaw JL, Abi-Jaoudeh N. VASCULAR INJURY AFTER HISTOTRIPSY: A CASE SERIES OF HEMORRHAGE AND PSEUDOANEURYSM COMPLICATIONS IN HUMAN PATIENTS. J Vasc Interv Radiol. 2026 Feb 6:108576. doi: 10.1016/j.jvir.2026.108576. PMID: 41655899
Nelson AT, Smith A, Curley CT, Kelly B, Ganesh AN, Peterson D, Fabyanic E, Kostuk E, Weber T, Engel EA. Systemic Administration of AAV9-G266A with Focused Ultrasound Enables Robust Brain Transduction with Minimal Liver Transduction. Hum Gene Ther. 2026 Feb 8:10430342251411044. doi: 10.1177/10430342251411044. PMID: 41656626
Falk KL, Wagner MG, Doucette S, Schluter T, Multu A, Kisting AL, Speidel M, Foltz GM, Ziemlewicz TJ, Lee FT Jr, Laeseke PF. Hepatic Histotripsy after Contrast Enhanced Ultrasound; Evaluation of Safety and Efficacy in an In Vivo Swine Model. J Vasc Interv Radiol. 2026 Feb 26:108610. doi: 10.1016/j.jvir.2026.108610. PMID: 41763601
Yu Y, Yan X, Gui Y, Lv K, Jiang Y. Prospects for clinical translation of histotripsy in liver applications: a systematic review based on preclinical studies. Quant Imaging Med Surg. 2026 Jan 1;16(1):92. doi: 10.21037/qims-2025-1137. Epub 2025 Dec 31. PMID: 41522007
Sarkar AR, Sahoo R, Jana NR. Ultrasound-Responsive Perfluorohexane Nanodroplets for Cell-Targeted Histotripsy and Therapy. ACS Appl Bio Mater. 2026 Feb 2;9(3):1311-1321. doi: 10.1021/acsabm.5c01590. Epub 2026 Jan 8. PMID: 41505765
Anthony GJ, Sammet S, Souris JS, Bader KB. Histotripsy-mediated reactive oxygen species generation in vitro. Ultrasonics. 2026 Mar;159:107885. doi: 10.1016/j.ultras.2025.107885. Epub 2025 Nov 9. PMID: 41240873
Yang Y, Zhang H, Shen Y, Yang F, Zhao D, Lin Y, Huang G. High-intensity focused ultrasound in the multimodal treatment of colorectal cancer liver metastases: A case report. Oncol Lett. 2026 Jan 7;31(3):98. doi: 10.3892/ol.2026.15451. eCollection 2026 Mar. PMID: 41551343
Wehrle CJ, Sayed Ahmed AF, Knott E, Hong H, Uysal M, Schlegel A, Berber E, Walsh RM, Kim J, Aucejo F, Kwon DCH. The first full year of histotripsy for liver tumors: Local tumor control and preliminary oncologic efficacy. Surgery. 2025 Dec 5:109898. doi: 10.1016/j.surg.2025.109898. PMID: 41353073
Rohfritsch A, Griffon A, Olhagaray E, Biénassis A, Barrot L, Muleki-Seya P, Melodelima D. Impact of focused ultrasound on the cellular network of liver tissue: a new perspective for thermal lesion detection. Phys Med Biol. 2025 Dec 29;71(1). doi: 10.1088/1361-6560/ae2bd8. PMID: 41380289
Wehrle CJ, Burns K, Mabud T, Ahmed AS, Alassas M, Juarez T, Ton J, Kim J, Aucejo F, Berber E, Ong E, Silk M, Hewitt B, Kwon DCH. Local Tumor Control of Liver Tumors After Histotripsy: A Preliminary National Multicenter Study. JCO Oncol Pract. 2025 Dec 16:OP2500550. doi: 10.1200/OP-25-00550. PMID: 41401400
Wong BO, Fan CM, Shyn PB, Wang J. Vascular complications following histotripsy of hepatocellular carcinoma. Int J Hyperthermia. 2025 Dec;42(1):2603108. doi: 10.1080/02656736.2025.2603108. Epub 2025 Dec 16. PMID: 41403239
Burns K, Juarez TM. Histotripsy for portal vein tumor thrombus in a patient with hepatocellular carcinoma: a case report. Front Oncol. 2025 Dec 2;15:1721814. doi: 10.3389/fonc.2025.1721814. eCollection 2025. PMID: 41409237
Gao Z, Yao L, Wei X, Wang S, Cao W, Deng W, Li X, Zhang Z, Wang S, Zhang Y, Li M, Xie Y. Progress in the Application of Nanobiotechnology in the Ablation Therapy of Hepatic Carcinoma. Int J Nanomedicine. 2025 Dec 15;20:15109-15133. doi: 10.2147/IJN.S551980. eCollection 2025. PMID: 41424453
Mundhava M, Vadodariya B, Jangid P, Shah A. Histotripsy Compared With Microwave Ablation, Radiofrequency Ablation, and Stereotactic Body Radiotherapy for the Treatment of Liver Tumors. Cureus. 2025 Dec 25;17(12):e100088. doi: 10.7759/cureus.100088. eCollection 2025 Dec. PMID: 41458348
Xie S, Ran L, Yang W, Zhou K, Jin C, Zhu H. Efficacy and safety of high-intensity focused ultrasound ablation under general anesthesia in older hepatocellular carcinoma patients. Front Oncol. 2025 Dec 11;15:1702332. doi: 10.3389/fonc.2025.1702332. eCollection 2025. PMID: 41458596
Haddad A, Vauthey JN. Are We Advancing Local Control of Liver Tumors With Histotripsy? Ann Surg. 2025 Dec 1;282(6):917-918. doi: 10.1097/SLA.0000000000006810. Epub 2025 Jun 25. PMID: 40560672
Song M, Thomas GPL, Khokhlova VA, Wang YN, Totten SI, Sapozhnikov OA, Schade GR, Khokhlova T. Doppler-based assessment of boiling histotripsy-induced volumetric tissue liquefaction in vivo. Ultrasonics. 2025 Dec;156:107775. doi: 10.1016/j.ultras.2025.107775. Epub 2025 Jul 29. PMID: 40752065
Mabud TS, Vergara M, Du J, Moore WH, Liu S, Bertino F, Taslakian B, Wolfgang C, Hewitt DB, Silk M. Histotripsy of Liver Metastases: Short-Term Safety and Imaging Findings. Cardiovasc Intervent Radiol. 2025 Nov;48(11):1594-1603. doi: 10.1007/s00270-025-04183-8. Epub 2025 Sep 28. PMID: 41016946
Chan AC, Lau VW, Wong GT, Chan YW, Man K, Ng LY, Ma H, Husain A, Ng IO. Prospective analysis on the outcomes of histotripsy for primary and metastatic liver tumours. Int J Surg. 2025 Nov 10. doi: 10.1097/JS9.0000000000003856. PMID: 41217432
Zhu Q, Ran R, Chen Q, Ren J, Qin Y, Zhang Y, Jiang M, Feng C, Zhu H, Shu S. Impact of valsalva maneuver duration on brain function in patients undergoing high-intensity focused ultrasound liver ablation: a randomized controlled trial. Int J Surg. 2025 Nov 13. doi: 10.1097/JS9.0000000000003885. PMID: 41231626
Jimenez-Soto C, Byrne MM, Loszko A, Endo Y, Nair A, Hernandez-Alejandro R, Oppenheimer D, Rubens D, Clark A, Bekki Y, Tomiyama K. First FDA approved experience with histotripsy for liver cancer management. Int J Surg. 2025 Nov 19. doi: 10.1097/JS9.0000000000004070. PMID: 41255274
Yeats E, Lu N, Sukovich J, Xu Z, Hall TL. Aberration correction expands the treatment envelope for histotripsy in the liver. Phys Med Biol. 2025 Nov 20. doi: 10.1088/1361-6560/ae222c. PMID: 41265042
Foltz GM, Kisting AL, Falk KL, Golden E, Laeseke P, Cho CS, Ziemlewicz T, Hinshaw JL, Koepsel EK, Lee FT Jr. An Emerging Paradigm Shift in Liver Ablation: The Potential for Clinical Impact of Nonthermal Ablation Technologies. J Vasc Interv Radiol. 2025 Dec;36(12):1868-1875. doi: 10.1016/j.jvir.2025.09.005. PMID: 41276365
Kim S, Majumdar A, Waters JP, Topper GV, Ghanem Y, Elbezanti W, Song S, Hong YK. Immunoresistant to immunosensitive – Histotripsy’s unique potential to overcome resistance. Crit Rev Oncol Hematol. 2025 Nov 27;217:105054. doi: 10.1016/j.critrevonc.2025.105054. PMID: 41317817
Ziemlewicz TJ, Critchfield JJ, Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Créixams X, Lubner M, Wah TM, Littler P, Davis CR, Narayanan G, White SB, Ahmed O, Collins ZS, Parikh ND, Planert M, Thormann M, Torzilli G, Solbiati LA, Cho CS. The #HOPE4LIVER Single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors: One-year Update of Clinical Outcomes. Ann Surg. 2025 Dec 1;282(6):908-916. doi: 10.1097/SLA.0000000000006720. Epub 2025 Apr 9. PMID: 40201962
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