HistoSonics Receives Singapore HSA Approval for Edison Histotripsy System

HistoSonics has received market authorization from Singapore’s Health Sciences Authority (HSA) for its Edison Histotripsy System, registered as the HistoSonics Histotripsy System. The approval marks another significant milestone in the company’s continued international expansion and creates new opportunities to advance access to histotripsy throughout the Asia-Pacific region.

The Edison System is a non-invasive, image-guided platform that uses the mechanical properties of focused ultrasound, known as histotripsy, to mechanically destroy and liquefy unwanted tissue and tumors without the need for invasive procedures, radiation, or thermal energy. The system is currently authorized for the destruction of liver tumors in the United States and select international markets, and received its first marketing authorization via FDA De Novo grant in October 2023, followed by CE Mark in July 2026.

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