About this approach
Histotripsy uses focused ultrasound pulses to create controlled acoustic cavitation that mechanically breaks down a planned volume of tissue. It does not use an incision, ionizing radiation, heat, or freezing. The FDA-authorized Edison system is used to identify, target, and destroy selected liver tumors while the team monitors the treatment with ultrasound imaging. The procedure still requires specialist imaging, anesthesia planning, and follow-up.
Where it fits: Nonthermal mechanical ablation of selected liver tumors
Where this treatment is used
The FDA granted De Novo authorization to the Edison System in October 2023 as a focused-ultrasound system for nonthermal mechanical tissue ablation. The reviewed clinical study included 44 participants with unresectable liver tumors and evaluated technical success and short-term safety. A later FDA 510(k) summary describes the system as identifying, targeting, and destroying liver tumors using focused ultrasound. Current clinical use is therefore centered on selected liver tumors rather than cancer throughout the body.
Procedure and practical considerations
Planning depends on whether the tumor can be visualized and reached safely with ultrasound and how close it is to vessels, bowel, lungs, or other structures.
Clinics reporting this approach
These clinic profiles mention this approach in their published materials. Open a profile to compare locations, services, practical details, and ways to get started.
Sources
Source information checked: 2026-10-01. The links below identify the public and clinic-provided materials used for this page.
- FDA De Novo DEN220087: Edison System decision record ↗Checked 2026-10-01
- FDA De Novo summary DEN220087: clinical evidence and device description ↗Checked 2026-10-01
- FDA 510(k) K241902: Edison System liver-tumor indication ↗Checked 2026-10-01
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