Edison System
HistoSonics, Inc.The Edison System is a non-invasive focused ultrasound device designed to mechanically destroy liver tumors using a non-thermal process called histotripsy. Integrated with diagnostic ultrasound imaging, it assists clinicians in precisely targeting and treating liver tumors without surgery, helping to improve liver cancer patient outcomes.
Intended Use
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.
Technology
The Edison System uses histotripsy, delivering high amplitude, very short focused ultrasound pulses to induce controlled acoustic cavitation at a focal location, creating a bubble cloud that mechanically destroys the liver tissue non-thermally. It includes a robotic treatment arm, therapy transducer, and coaxially aligned diagnostic ultrasound probe integrated with a GE LOGIQ E10s system.
Performance
Performance testing included electrical safety, electromagnetic disturbance, acoustic characterization, software lifecycle validation, and system/subsystem verification. A GLP-compliant preclinical animal study in a porcine model demonstrated safety and effectiveness equivalent to predicate devices. Usability testing and biocompatibility assessments were also compliant with relevant standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/1/2024
4 months - 2
FDA Approval
10/30/2024
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