US-based non-invasive focused ultrasound technology developer HistoSonics has secured regulatory clearance in Singapore for its Edison histotripsy system from the Health Sciences Authority (HSA).
The platform uses a technique called histotripsy, in which precisely targeted ultrasound waves generate mechanical forces capable of breaking apart and liquefying tumours.
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According to HistoSonics, the approach is entirely non-invasive and avoids both ionising radiation and heat-based tissue destruction.
The company added that the approval carries significance beyond Singapore’s borders.
Several Asia-Pacific countries, among them Malaysia, Thailand, Australia and the Philippines, operate regulatory reliance frameworks that can allow devices carrying HSA authorisation to undergo accelerated assessment processes. Individual country requirements still apply.
The clearance is expected to help HistoSonics pursue a broader regional footprint from a single regulatory milestone.
HistoSonics chairman and CEO Mike Blue said: “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.
“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.”
In the US, the Edison system is currently approved for liver tumour treatment and selected overseas markets, having first received marketing authorisation via a US Food and Drug Administration (FDA) De Novo grant in October 2023. European CE Mark approval followed in July 2026.
In June 2026, HistoSonics completed a new financing round that valued the company at $3.75bn, with participation from Reed Jobs and Yosemite.
