HistoSonics' Edison Histotripsy System Earns Taiwan FDA Approval for Non-Invasive Liver Tumor Treatment
Key Insights
HistoSonics (search) received Taiwan Food and Drug Administration (TFDA) approval for the Edison Histotripsy System (search), marking a significant milestone in the company's Asia-Pacific expansion.
The Edison System uses non-invasive, non-thermal focused ultrasound to mechanically liquefy and destroy targeted liver tumors (search) without surgery or radiation.
National Taiwan University Hospital served as the first installation site, achieving one of the fastest rates of clinical adoption for histotripsy globally under research protocols.
HistoSonics (search), the developer of the novel histotripsy therapy platform, announced it has received regulatory approval from the Taiwan Food and Drug Administration (TFDA) for the Edison Histotripsy System (search). The decision represents a significant milestone in the company's global expansion strategy and continued growth across the Asia-Pacific region, adding to prior clearances from the U.S. FDA and European regulatory authorities.
The TFDA approval process included a detailed review of the company's clinical and regulatory submission package and concluded with unanimous agreement from committee members. Taiwan is widely recognized as one of the most advanced and strategically important medical device markets in the region, known for its rigorous regulatory standards and highly innovative physician community.
"This approval is an important milestone for HistoSonics (search), and the advancement of histotripsy throughout Asia," said Mike Blue, Chairman and CEO of HistoSonics. "Receiving TFDA approval underscores the strength of our clinical evidence, the rigor of our regulatory work, and the growing confidence in histotripsy as a transformative non-invasive therapy platform."
A Novel Non-Invasive Mechanism of Action
The Edison System employs histotripsy, a non-invasive, non-thermal focused ultrasound technology designed to mechanically liquefy and destroy targeted tissue and tumors without the need for surgery or radiation. Unlike thermal ablation techniques, histotripsy uses acoustic cavitation to mechanically disrupt cells at the subcellular level, offering a fundamentally different approach to tumor destruction.
Currently, the Edison System is indicated for the non-invasive destruction of liver tumors (search), including unresectable liver tumors. The system continues to be evaluated for additional applications in kidney, pancreas, prostate, and other anatomical locations.
Clinical Momentum at National Taiwan University Hospital
HistoSonics (search) has established a strong clinical presence in Taiwan through National Taiwan University Hospital (NTUH), the company's first installation site in the country. While awaiting TFDA approval, physicians at NTUH treated patients under research protocols and achieved one of the fastest rates of clinical adoption for histotripsy globally.
Under these research protocols, physicians at NTUH have already treated a broad range of tumor types using histotripsy, including liver tumors (search), kidney tumors (search), pancreatic tumors (search), and sarcoma (search) cases. Their early clinical experience continues to expand the understanding of the potential applications of histotripsy therapy across multiple organ systems.
"Our early clinical experience with histotripsy has been very encouraging, not only for liver tumors (search) but also for exploring future applications in other difficult-to-treat diseases," said Kai-Wen Huang, Professor of Surgical Oncology at National Taiwan University Hospital. "Receiving TFDA approval is an important milestone for Taiwan and for Asia. We are excited to continue contributing to the clinical development and adoption of histotripsy in the region."
Building on Global Regulatory Success
The Taiwan approval follows the Edison System's FDA clearance in October 2023, which marked the first time histotripsy earned regulatory approval worldwide for the treatment of liver tumors (search). The system subsequently received CE Mark approval in Europe, supported by clinical data from the #HOPE4LIVER pivotal trial, which enrolled patients across the United States and Europe.
In that trial, after 12 months of follow-up, participants experienced a 90% rate of local tumor control across all treated tumors regardless of tumor type or origin. Overall survival at one year was 73.3% for patients with primary liver cancer and 48.6% for patients with metastatic disease.
"Histotripsy represents a fundamentally new way to treat patients, using focused ultrasound to mechanically destroy tumors and tissue without the invasiveness or toxicity of traditional procedures," Blue stated following the European approval.
In August 2025, HistoSonics (search) was acquired by a group of globally recognized private and public investors, valuing the company at $2.25 billion, further underscoring the commercial and clinical potential of the histotripsy platform.
Future Directions
With TFDA approval secured, HistoSonics (search) plans to expand collaborations with leading physicians and institutions throughout Taiwan and Asia, with a focus on generating high-quality clinical evidence, advancing additional indications through clinical research, and developing advanced physician training and education programs throughout the region. The company is also investigating additional indications including benign prostatic hyperplasia (search), kidney tumors (search), and pancreatic cancer.