MINNEAPOLIS — HistoSonics, developer of the Edison Histotripsy System and its novel non-invasive therapy platform, announced that Elevance Health (formerly Anthem, Inc.) has issued a positive medical policy covering the use of histotripsy for the treatment of liver tumors.
Effective October 21, 2025, the decision extends insurance coverage across Elevance Health’s commercial, Medicare, and Medicaid plans in 14 states, including California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, New York, Ohio, Virginia, and Wisconsin. The policy will provide access to HistoSonics’ incisionless, non-thermal liver tumor therapy for approximately 45.4 million members.
“This coverage expansion by Elevance Health represents another critical milestone in increasing access to histotripsy for patients who urgently need non-invasive treatment options,” said Mike Blue, Chairman and CEO of HistoSonics. “We are deeply grateful to our clinical partners who continue to generate strong evidence validating the safety, precision, and effectiveness of histotripsy, and to the growing number of payers recognizing its value in improving outcomes for patients with liver tumors. Liver metastases contribute to nearly half of all cancer-related deaths worldwide, highlighting the urgent need for non-invasive solutions that can improve both survival and quality of life.”
The Edison Histotripsy System received FDA De Novo authorization in October 2023 for the non-thermal destruction of liver tumors. The system uses focused ultrasound energy to mechanically liquefy targeted tissue at the cellular level without incisions, radiation, or heat. Results from the #HOPE4LIVER pivotal trial demonstrated a 90 percent local tumor control rate at 12 months across treated tumor types, comparable to existing ablative therapies but with fewer complications and shorter recovery times. Long-term and real-world registry data are now being collected to further support these findings.
Elevance Health’s decision adds to a growing wave of insurer adoption nationwide. The new coverage builds on earlier policies from several Blue Cross Blue Shield plans and complements recognition by the United Network for Organ Sharing (UNOS), which lists histotripsy as an approved loco-regional therapy option for liver transplant candidates.
The Edison System is designed for the non-invasive mechanical destruction of liver tumors, including the partial or complete ablation of unresectable tumors using histotripsy. While the system has received authorization for tissue destruction, the FDA has not yet evaluated it for treatment outcomes such as local tumor control or survival rates.
The device is intended for use only by physicians who have completed HistoSonics-provided training. Clinical decisions should be guided by the judgment of qualified healthcare professionals. Full warnings, precautions, and trial data are available in the device’s Instructions for Use.
