HistoSonics Receives TFDA Approval in Taiwan for Edison Histotripsy System, Accelerating Asia Expansion
May 18, 2026 – 5:36 pm
Summary:
HistoSonics has secured Taiwan Food and Drug Administration (TFDA) approval for its Edison Histotripsy System, a non-invasive focused ultrasound device that destroys tumours without cutting, radiation, or thermal damage. Valued at $2.25 billion, the company is expanding across Asia while pursuing US FDA authorization for kidney tumours.
HistoSonics’ Breakthrough Technology: Histotripsy
Histotripsy is a non-thermal mechanical process that utilizes precisely focused sound waves to generate controlled acoustic cavitation. These microscopic bubbles expand and collapse with enough force to destroy targeted tissue at the subcellular level, without heating surrounding areas. Unlike thermal ablation or radiation therapy, histotripsy mechanically liquefies tissue, allowing the body’s immune system to naturally absorb and clear the destroyed tissue.
Edison System: Pioneering Histotripsy in Clinical Practice
The Edison system, developed over two decades at the University of Michigan by HistoSonics, received its initial US FDA De Novo authorization in October 2023 for non-invasive destruction of liver tumours, including unresectable ones. One-year clinical data from a pivotal trial showed a 90% tumor control rate.
Expanding Horizons: Asia and Beyond
The TFDA approval marks a significant step in HistoSonics’ expansion into Asia. The company has already established a clinical presence in Taiwan through the National Taiwan University Hospital, where physicians treated patients under research protocols with encouraging results. This rapid adoption underscores histotripsy’s potential to revolutionize cancer treatment globally.