HistoSonics today announced that it has received market authorization from the Health Sciences Authority (HSA) in Singapore. The approval by HistoSonics Singapore includes the Edison® Histotripsy System, which is named the HistoSonics Histotripsy System. This milestone is another important step in the company’s international expansion. It also creates new pathways for increasing access to histotripsies in the Asia-Pacific region.
The Edison System is a novel, non-invasive, image-guided platform. It uses the mechanical properties of focused ultrasound, known as histotripsy. This process mechanically destroys and liquefies unwanted tissue and tumors. As a result, the technology offers a fundamentally new approach to tissue destruction. Physicians do not need invasive procedures, radiation, or thermal energy. Currently, the system holds authorization for destroying liver tumors in the United States and select international markets.
“Receiving HSA registration in Singapore represents another important step in HistoSonics’ global expansion and our commitment to bringing histotripsy to more physicians and patients around the world,” said Mike Blue, Chairman and Chief Executive Officer of HistoSonics. “Singapore is an important healthcare and innovation hub for the Asia-Pacific region, and this approval creates opportunities that extend well beyond the Singapore market. As we continue to build our presence in Asia, we look forward to working with leading healthcare institutions and physicians to advance clinical experience, expand access to this technology, and support the growing global interest in histotripsy.”
Why is Singapore Important for HistoSonics
Singapore is a strategically important market for HistoSonics. The nation is a regional nexus for health care innovation, clinical collaboration and cutting-edge medical technology. In addition to the HistoSonics Singapore approval, HSA registration may also facilitate regulatory submissions in several other markets. They include Malaysia, Thailand, Australia and the Philippines. There are existing international programs of reliance on regulation. HSA eligible and registered medical devices may be subject to a streamlined regulatory review. Individual country requirements still apply, however.
This is a key milestone and shows how Singapore is emerging as a global leader in medical devices. In March 2026, the World Health Organization awarded the Health Sciences Authority Maturity Level 4, the first national regulatory body in the world to get such a status. This is the highest maturity level of the WHO benchmarking tool for medical device regulatory systems. This makes Singapore an internationally reputable regulatory authority and an important benchmark tool for medical technology markets globally.
Expanding Presence in Asia
Since May 2025, when our first Histotripsy Training Centre was opened in Asia at Gleneagles Hospital Hong Kong, HistoSonics has continued to make progress across the region. Our focus has been on education, clinical collaboration and partnerships. Since opening our first centre, we have had growth with more physicians being trained and observed through our centre. The centre now provides a resource for physicians within the region to gain practical experience with histotripsy. Support is provided to physicians to ensure they can develop successful programmes within their institution.
HistoSonics continues to execute its global commercialization strategy with regulatory approvals in the U.S., Europe, Singapore and other international markets. At the same time, the company is also expanding its clinical research. Future applications in other organs such as the kidney, pancreas and prostate are also planned. The Edison Histotripsy System received its first marketing authorization in October 2023, via an FDA De Novo grant, and the HistoSonics Singapore approval builds on this.
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News Source: Businesswire.com
