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.
Singapore represents a strategic market for HistoSonics, serving as a regional center for healthcare innovation, clinical collaboration, and advanced medical technology. Beyond establishing a pathway for commercialization within Singapore, HSA registration may also support regulatory submissions in several additional markets through established international regulatory reliance programs, including Malaysia, Thailand, Australia, and the Philippines, where qualifying devices registered by HSA may be eligible for streamlined review subject to individual country requirements. The milestone comes as Singapore continues to strengthen its position in medical device regulation, with the World Health Organization recognizing the Health Sciences Authority in March 2026 as the first national regulatory authority globally to achieve Maturity Level 4, the highest classification under WHO’s benchmarking framework for medical device regulatory systems.
HistoSonics has continued to expand its presence across Asia through physician education, clinical collaboration, and strategic partnerships. In May 2025, the company established its first Histotripsy Training Center in Asia at Gleneagles Hospital Hong Kong, which has since expanded to accommodate growing demand for physician training, clinical observation, and multidisciplinary education. With regulatory approvals in the United States, Europe, Singapore, and other international markets, HistoSonics continues to advance its global commercialization strategy while expanding clinical research and future applications of histotripsy across additional organs including the kidney, pancreas, and prostate.
Mike Blue, Chairman and Chief Executive Officer of HistoSonics, said receiving HSA registration in Singapore represents another important step in the company’s global expansion and its commitment to bringing histotripsy to more physicians and patients around the world. Blue noted that Singapore is an important healthcare and innovation hub for the Asia-Pacific region, and that the approval creates opportunities extending well beyond the Singapore market. Blue added that as HistoSonics continues to build its presence in Asia, it looks forward to working with leading healthcare institutions and physicians to advance clinical experience, expand access to the technology, and support growing global interest in histotripsy.
