Taiwan Approval Boosts Histotripsy Expansion

HistoSonics, the developer of the Edison® Histotripsy System, has received approval from the Taiwan Food and Drug Administration (TFDA) for its innovative non-invasive therapy platform. This approval marks a crucial step in the company’s global expansion, particularly across Asia. The TFDA’s decision follows an extensive review of HistoSonics’ clinical and regulatory submissions, culminating in unanimous committee support. Taiwan is a pivotal market in the region, renowned for its stringent regulatory standards and forward-thinking medical community.

HistoSonics’ Edison System employs histotripsy, a non-thermal focused ultrasound technology, to mechanically liquefy and destroy targeted tissue and tumours without surgery or radiation. The approval further reinforces the growing clinical and regulatory momentum behind histotripsy. National Taiwan University Hospital (NTUH) has been the company’s first installation site in Taiwan, where physicians treated patients under research protocols while awaiting TFDA approval.

Clinical Adoption and Future Plans

“This approval is an important milestone for HistoSonics, 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.” Physicians at NTUH have conducted research protocols using the Edison System, achieving rapid clinical adoption for histotripsy globally. Professor Kai-Wen Huang from NTUH expressed enthusiasm about the approval, noting significant progress in treating liver tumours and exploring applications for other challenging conditions.

With TFDA approval, HistoSonics plans to expand collaborations with leading physicians and institutions throughout Taiwan and Asia. The focus will be on generating high-quality clinical evidence and developing advanced physician training programmes. Currently, the Edison System is approved for non-invasive liver tumour destruction, including unresectable cases. It is also under evaluation for potential applications in kidney, pancreas, and prostate treatments.

Taiwan’s approval adds momentum to histotripsy’s global clinical and regulatory development. HistoSonics’ initial success in Taiwan highlights the system’s potential to address unmet medical needs in other Asian markets. Physicians at NTUH have already treated a broad range of tumour types using histotripsy, including liver, kidney, pancreatic tumours, and sarcoma cases. Their early clinical experience continues to expand the understanding of the potential applications of histotripsy therapy across multiple organ systems.

Last updated: 29 June 2026, 12:05 pm