Plymouth, MN-based focused ultrasound developer HistoSonics has received market authorization from Singapore’s Health Sciences Authority (HSA) for its Edison Histotripsy System.
The image-guided system uses focused ultrasound to mechanically destroy and liquefy targeted tissue without incisions, radiation, or thermal energy, according to the vendor. It is authorized for destroying liver tumors in the U.S. and in select international markets. The U.S. Food and Drug Administration (FDA) granted it De Novo authorization in October 2023.
HSA registration may support streamlined regulatory review in Malaysia, Thailand, Australia, and the Philippines through regional reliance programs, subject to each country’s requirements, according to the company. HistoSonics is also exploring histotripsy applications in the kidney, pancreas, and prostate, it said.
