MINNEAPOLIS, Minn., July 13, 2026
HistoSonics has achieved a major international regulatory milestone after receiving CE Mark approval for its Edison® Histotripsy System, enabling commercialization of the company’s groundbreaking non-invasive focused ultrasound platform across Europe and other global markets recognizing the CE Mark. The approval significantly expands global access to the Edison System, an innovative image-guided histotripsy technology designed for the mechanical destruction of liver tumors without surgery, needles, radiation, or thermal ablation. Histotripsy utilizes highly focused ultrasound energy to liquefy and destroy targeted tissue while preserving surrounding healthy structures, representing a transformative advancement in minimally invasive oncology care. The CE Mark follows a series of regulatory achievements for the company, including the U.S. FDA De Novo clearance received in October 2023, and strengthens HistoSonics’ global commercialization strategy as demand continues to grow for safer, precision-guided alternatives to conventional liver tumor treatments. Supported by strong clinical evidence demonstrating favorable safety and effectiveness, the latest approval positions the Edison System as one of the most innovative therapeutic technologies entering the European medical device market.
Clinical Evidence Supports Innovative Liver Tumor Treatment
The CE Mark approval was supported by an expanding body of clinical data, including findings from the multinational #HOPE4LIVER pivotal clinical trial, which enrolled patients across the United States, Germany, Italy, Spain, and the United Kingdom. Results from the study demonstrated an impressive 90% local tumor control rate at 12 months, accompanied by a low complication rate, highlighting the technology’s ability to precisely destroy liver tumors while minimizing injury to surrounding healthy tissue. Unlike conventional thermal ablation, surgery, or radiation therapy, histotripsy relies on the mechanical effects of focused ultrasound rather than heat, reducing many of the risks associated with invasive cancer treatments. The Edison System is intended for the partial or complete destruction of unresectable liver tumors, offering physicians a valuable treatment option for patients who are not suitable candidates for surgery because of tumor location, underlying liver disease, or other medical considerations. Long-term follow-up studies continue to evaluate durability and broader real-world outcomes as clinical adoption expands.
European Commercial Rollout Accelerates Global Expansion
Following regulatory approval, HistoSonics plans a phased commercial launch of the Edison Histotripsy System across Europe, initially partnering with leading centers of excellence specializing in liver tumor treatment. The company expects these collaborations to accelerate physician training, generate additional clinical evidence, and support broader adoption throughout European healthcare systems. Histotripsy represents an entirely new therapeutic approach by enabling physicians to mechanically liquefy tumors without surgical incisions or ionizing radiation, potentially reducing patient recovery time while improving treatment precision. Company leadership believes the European approval will further establish histotripsy as a next-generation treatment platform capable of addressing significant unmet clinical needs in liver oncology and creating opportunities for expansion into additional disease areas.
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Platform Expansion Extends Beyond Liver Oncology
While the Edison System is currently approved for treating liver tumors, HistoSonics continues advancing research evaluating histotripsy applications in kidney, pancreas, prostate, and other organs, reflecting the platform’s broad future potential across multiple therapeutic specialties. The company remains focused on advancing non-invasive medical technologies that improve patient outcomes through precision tissue destruction while minimizing complications associated with traditional procedures. As healthcare systems increasingly adopt image-guided and minimally invasive interventions, the CE Mark approval reinforces HistoSonics’ position as a global innovator in medical ultrasound technology and interventional oncology. The milestone also strengthens the company’s long-term commercialization strategy by expanding patient access to cutting-edge, radiation-free tumor treatment solutions that have the potential to redefine the future of surgical oncology and image-guided therapy.
Source: HistoSonics press release
