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Given limited clinical experience, synthesis of pre-clinical and early clinical data is essential to guide safe adoption. A PubMed and SCOPUS search was performed focused on pre-clinical and clinical adverse events (AEs) from Histotripsy ablation of parenchymal tissues in vivo (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009141 total studies,\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200927 clinical reports). Early data suggest an acceptable acute safety profile in select settings; however, reports of serious AEs including pre-clinical bowel perforations, clinical acute kidney injuries, clinical vascular injuries and thromboses, and a clinical case report of hyperprogression raise caution. These highlight the need for proper technique, understanding of mechanism nuances, and longer-term follow-up to assess effects. Recognition of mechanism-specific AEs provides a framework to guide future assessments and safer adoption of Histotripsy.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Level of Evidence<\/jats:bold>\n                    \u00a0No level of evidence (review).\n                  <\/jats:p>","DOI":"10.1007\/s44343-026-00062-2","type":"journal-article","created":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T13:03:25Z","timestamp":1791810205000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Understanding histotripsy ablation safety: a systematic review of pre-clinical and clinical adverse events"],"prefix":"10.1007","volume":"2","author":[{"given":"Madeline I.","family":"Foo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Uzoukwu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Morhard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrina L.","family":"Falk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradford J.","family":"Wood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Frey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy J.","family":"Ziemlewicz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Vlaisavljevich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beau B.","family":"Toskich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8561-8288","authenticated-orcid":false,"given":"Alissa","family":"Hendricks-Wenger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,12]]},"reference":[{"key":"62_CR1","doi-asserted-by":"publisher","unstructured":"Abi-Jaoudeh N, Ziemlewicz TJ, White S, Wah T, Cho C. 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Ann Surg. 2025;282(6):908-16.","DOI":"10.1097\/SLA.0000000000006720"}],"container-title":["CVIR Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s44343-026-00062-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s44343-026-00062-2","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s44343-026-00062-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T17:27:15Z","timestamp":1791826035000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s44343-026-00062-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,12]]},"references-count":116,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["62"],"URL":"https:\/\/doi.org\/10.1007\/s44343-026-00062-2","relation":{},"ISSN":["3059-2003"],"issn-type":[{"value":"3059-2003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,12]]},"assertion":[{"value":"26 May 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 September 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 October 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This article does not contain any prospective new studies with human participants or animals performed by any of the authors and is a retrospective review of peer-reviewed previously published literature and may be exempt from usual human research approval pathways. For this type of study informed consent is not required.","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"For this type of study, consent for publication is not required.","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"M.F., C.I., R.M., G.F., and A.H.W. declare that they have no conflict of interest. K.F is a consultant for HistoSonics,Inc. BW declares the following conflicts: employee of DeepSight Technology, Inc, receives royalties as inventor from an NIH-Philips licensing agreement. BW had recent research support from NVIDIA, Philips, Siemens Healthineers, Varian Interventional Systems, Canon Medical, MediView, Boston Scientific, Quantum Surgical\/Precision Oncology, Immunophotonics, ProMaxo, Profound Medical, Clinical Laserthermia Systems, Tempus, Avenda Health, Angiodynamics, Galvanize. BW is a named inventor on intellectual property in the space of therapeutic ultrasound. BW is on the data safety monitoring board of Quantum Surgical. T.Z. declares the following conflicts: Histosonics- Consultant, Research support, Shareholder; Ethicon\/Neuwave- Research support; Elephas- Consultant. E.V. is co-founder of Sound Blade Medical and has had research partnerships with HistoSonics. B.B.T. is a consultant for AstraZeneca, Boston Scientific, Genentech, Eisai, Sirtex, Replimune, ABK, BD, Terumo, Galvanize, Turnstone Biologics, Johnson and Johnson, HistoSonics, and Vivos.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"33"}}