HistoSonics announcement that the Edison System received CE Mark approval in Europe for destruction of liver tumors.
Histotripsy
Histotripsy is a nonthermal focused-ultrasound ablation method that mechanically destroys selected tumor tissue with cavitation bubble clouds rather than heat, incision, needles, or radiation. Its strongest current cancer use is local destruction of selected primary or metastatic liver tumors; kidney, pancreas, prostate, and other solid-tumor uses remain investigational.
HistoSonics announcement of a De Novo submission to FDA seeking authorization for destruction of kidney tumors.
Systematic review and meta-analysis summarized by HistoSonics as including 10 papers and 553 patients, with 94.1% technical success and about 7.0% major complications.
News report on early European/NHS clinical access to histotripsy outside trials.
Business coverage of HistoSonics valuation, treated-patient count, liver tumor use, and kidney study plans.
One-year follow-up of #HOPE4LIVER, listed by HistoSonics as reporting 90% local tumor control and one adverse device effect after 30 days.
Safety analysis of 230 histotripsy cases listed by HistoSonics clinical evidence materials.
Pivotal single-arm trial of histotripsy for primary and metastatic liver tumors, listed by HistoSonics as reporting 95% technical success and 7% major complication rate.
Business coverage of HistoSonics financing and commercial rollout of histotripsy for liver tumors.
Review-style article framing the promise and limits of histotripsy innovation.
Preclinical cancer-focused histotripsy article listed in public histotripsy bibliographies.
FDA De Novo summary for the Edison System, classifying the device as a focused ultrasound system for non-thermal mechanical tissue ablation and listing its liver tumor indication and limitations.
Narrative review of histotripsy research progress and clinical evaluation.
First-in-human feasibility study of hepatic histotripsy in selected patients with primary and secondary liver tumors.
Histotripsy: the first noninvasive, non-ionizing, non-thermal ablation technique based on ultrasound
Review article describing histotripsy as a non-invasive, non-ionizing, nonthermal ultrasound ablation technique.
Preliminary national multicenter study of local tumor control after liver tumor histotripsy.