HistoSonics has obtained TFDA approval in Taiwan for the Edison Histotripsy System, which speeds up its expansion in Asia.

      HistoSonics has received approval from Taiwan's Food and Drug Administration (TFDA) for its Edison Histotripsy System, a non-invasive ultrasound device that eliminates tumors without surgical intervention or radiation. The company, valued at $2.25 billion, is expanding its presence in Asia while actively seeking authorization from the US FDA for treating kidney tumors.

      The regulatory approval, announced on May 18, represents a pivotal advancement in HistoSonics' efforts to penetrate the Asian market, adding Taiwan to the list of countries where the technology is now available commercially. The approval process included a unanimous agreement from the review committee. HistoSonics has established a clinical foothold in Taiwan through the National Taiwan University Hospital, the first facility in the country to adopt the system, where doctors have treated patients under research protocols and have seen one of the quickest clinical adoption rates worldwide.

      Understanding histotripsy and its significance

      Histotripsy is a mechanical, non-thermal process that utilizes precisely directed sound waves to induce controlled acoustic cavitation, forming microscopic bubbles that expand and collapse forcefully enough to destroy target tissues at a subcellular level. Unlike thermal ablation that burns tumors or radiation therapy that damages DNA, histotripsy liquefies tissue mechanically without heating surrounding areas. The destroyed tissue is then naturally cleared by the body's immune system.

      The Edison system, developed over more than 20 years based on research from the University of Michigan, received initial US FDA De Novo authorization in October 2023 for the non-invasive destruction of liver tumors, including those that cannot be surgically removed. This approval made Edison the only histotripsy platform authorized in the United States. Clinical data from a pivotal trial indicates a 90 percent tumor control rate, drawing interest from oncologists treating patients not eligible for surgery.

      HistoSonics as a company

      HistoSonics, founded in 2009 in Ann Arbor, Michigan, is not a fledgling startup. In August 2025, the company was valued at $2.25 billion after a group of investors, including K5 Global, Bezos Expeditions, and Wellington Management, acquired a majority stake. This transaction led to CEO Mike Blue taking on the role of board chairman, followed by a $250 million growth financing round led by K5 Global, with contributions from Thiel Bio and Founders Fund. The company has raised over $560 million across 11 funding rounds.

      The list of investors includes notable names in technology and investment circles. The involvement of Jeff Bezos’s investment firm and Peter Thiel’s biotech fund underscores the belief that histotripsy is a foundational technology with potential applications extending beyond liver treatment, possibly addressing kidney, pancreatic, and prostate tumors. The acquisition of French AI ultrasound startup Sonio by Samsung for €86 million highlights a broader trend of significant investments in ultrasound technologies, although HistoSonics’ application is more ambitious than merely diagnostic imaging.

      The TFDA approval is crucial for two reasons. Firstly, Taiwan boasts a sophisticated healthcare system with significant research capacity, making it an ideal location for generating the clinical data required by regulatory bodies in other Asian markets. Secondly, this approval coincides with HistoSonics’ pursuit of multiple regulatory and clinical milestones.

      Taipei Veterans General Hospital has already acquired an Edison system, with its director comparing the technology to a legendary weapon and announcing plans to treat 50 patients with liver cancer or metastases at no cost within six months as part of a clinical trial. This acquisition was reportedly inspired by a donation of a histotripsy system to the University of Hong Kong in 2024 from billionaire Li Ka-shing, showing how philanthropic actions can speed up commercial adoption in new regions.

      HistoSonics aims to enhance partnerships with physicians and institutions across Taiwan and the Asia-Pacific region, focusing on generating clinical data, expanding treatment indications through research, and developing training programs for medical professionals. According to its latest updates, the company has treated over 2,000 patients at more than 50 operational centers worldwide.

      Next steps beyond liver treatment

      Just a week prior to the Taiwan approval, on May 11, HistoSonics submitted a De Novo application to the US FDA for authorization to extend the Edison system’s capabilities to treat kidney tumors. This submission is backed by the HOPE4KIDNEY pivotal trial, which enrolled 67 patients and finished enrollment in June 2025. CEO Mike Blue highlighted this submission as a significant step towards expanding histotripsy treatment to kidney issues, an area where both patients and doctors are looking for organ-preserving alternatives.

      The kidney indication is particularly important as small renal masses are often found incidentally during imaging, and many patients, especially the elderly or those with comorbidities, may not be suitable for surgery. A non-invasive, non-thermal treatment option that preserves kidney function could fulfill a genuine need in the treatment landscape. Beyond kidneys, HistoSonics is also exploring the technology for pancreatic