HistoSonics receives TFDA approval in Taiwan for Edison Histotripsy System, accelerating Asia expansion

HistoSonics received Taiwan TFDA approval for the Edison Histotripsy System, a non-invasive focused ultrasound device for tumour destruction. The system uses precisely focused sound waves to create controlled acoustic cavitation, producing microscopic bubbles that expand and collapse with enough force to destroy targeted tissue at the subcellular level. The process is non-thermal and mechanically liquefies tissue without heating surrounding areas, unlike thermal ablation or radiation therapy. The destroyed tissue is absorbed and cleared naturally by the body’s immune system. The approval follows a regulatory review that concluded with unanimous committee agreement. HistoSonics already has a clinical presence in Taiwan through National Taiwan University Hospital, where physicians treated patients under research protocols and reported rapid adoption. The company is expanding across Asia and pursuing US FDA authorisation for kidney tumours.

"HistoSonics has received regulatory approval from Taiwan's Food and Drug Administration for its Edison Histotripsy System, a non-invasive cancer treatment device that uses focused ultrasound to destroy tumours without cutting, radiation, or thermal damage. The TFDA authorisation, announced on 18 May, marks a significant step in the company's expansion into Asia and adds Taiwan to a growing list of markets where the technology is commercially available."

"Histotripsy is a non-thermal mechanical process that uses precisely focused sound waves to create controlled acoustic cavitation, essentially microscopic bubbles that expand and collapse with enough force to destroy targeted tissue at the subcellular level. Unlike thermal ablation techniques that burn tumours, or radiation therapy that damages DNA, histotripsy mechanically liquefies tissue without heating the surrounding area. The destroyed tissue is then absorbed and cleared naturally by the body's immune system."

"The approval follows a regulatory review process that the company said concluded with unanimous agreement from committee members. HistoSonics has already established a clinical presence in Taiwan through the National Taiwan University Hospital, the first institution in the country to install the system, where physicians treated patients under research protocols and achieved what the company describes as one of the fastest clinical adoption rates globally."

"The Edison system, which HistoSonics developed over more than two decades from research originating at the University of Michigan, received its initial US FDA De Novo authorisation in October 2023 for the non-invasive destr"

Read at TNW | Asia