HistoSonics Wins Singapore Authorization for Edison Histotripsy System

HistoSonics said on November 2 that it has received market authorization from Singapore's Health Sciences Authority (HSA) for its Edison Histotripsy System, which is registered there under the device name HistoSonics Histotripsy System.

The announcement was distributed by Business Wire, read via Medianet's News Hub. HistoSonics, a privately held company with offices in Ann Arbor, Michigan, Minneapolis and Madison, Wisconsin, did not say in the release when it expects to treat the first patients in Singapore or which hospitals will use the system.

What the system does

The Edison System is an image-guided platform that uses focused ultrasound to mechanically destroy and liquefy tissue, a technique known as histotripsy, according to the company. HistoSonics says the approach works without invasive procedures, radiation or thermal energy.

"The Edison System is currently authorized for the destruction of liver tumors in the United States and select international markets," the release states. The system received its first marketing authorization through an FDA De Novo grant in October 2023, the company said.

A wider Asia-Pacific pathway

HistoSonics said HSA registration may help it seek approval elsewhere in the region through international regulatory reliance programs. The company named Malaysia, Thailand, Australia and the Philippines as markets where qualifying devices registered by HSA "may be eligible for streamlined regulatory review, subject to individual country requirements."

The release also notes that in March 2026, the World Health Organization recognized HSA as the first national regulatory authority to reach Maturity Level 4 under its benchmarking framework for medical device regulation.

"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," chairman and CEO Mike Blue said in the release.

The Singapore decision follows other international clearances this year. According to HistoSonics' newsroom feed, the company announced approval from Taiwan's Food and Drug Administration on May 18 and the CE Mark in Europe on July 13, and opened an expanded histotripsy training center in Hong Kong on July 20. The company first set up that center at Gleneagles Hospital Hong Kong in May 2025, the release says.

Beyond the liver

HistoSonics said it is expanding clinical research into other organs, including the kidney, pancreas and prostate. Its newsroom feed lists a May 11 announcement of an FDA submission for kidney tumors and a March 30 announcement that the first patients had been treated in an evaluation of the system for benign prostatic hyperplasia. Those uses are not part of the Singapore authorization described in the release.