HistoSonics gets Taiwan approval for its tumour-destroying ultrasound system as it pushes into Asia

TL;DR

HistoSonics has received Taiwan TFDA approval for its Edison Histotripsy System, a non-invasive focused ultrasound device that destroys tumours without cutting or radiation. The company, valued at $2.25 billion, is expanding across Asia while 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.

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...

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