October 5, 2020
HistoSonics Announces Approval of its #HOPE4LIVER US Clinical Study
HistoSonics announced today that it has received approval of an Investigational Device Exemption (IDE) from the U.S. Food and Drug […]
You are leaving the HistoSonics® website, which includes discussions the benefits and risk of histotripsy and the indications for use statement for the Edison® System. You are being re-directed to publicly available information from a third party. HistoSonics is not responsible for third-party information and does not intend to promote any off-label use of the Edison® System or any clinical uses/benefits that have not been evaluated in an appropriately controlled clinical study.
Last updated on September 3, 2024
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
The Edison® System is intended for the non-invasive mechanical destruction of liver tumors, including the partial or complete destruction of unresectable liver tumors via histotripsy. The FDA has not evaluated the Edison System for the treatment of any disease including, but not limited to, cancer or evaluated any specific cancer outcomes (such as local tumor progression, 5-year survival or overall survival). The System should only be used by persons who have completed training performed by HistoSonics, and its use guided by the clinical judgment of an appropriately trained physician. Refer to the device Instructions for Use for a complete list of warnings, precautions and a summary of clinical trial results, including reported adverse events.
