HistoSonics Breakthrough Device That Destroys Liver Tumors Gets FDA Nod

HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first histotripsy platform available in the U.S.

Histotripsy uses focused ultrasound to produce controlled acoustic cavitation that mechanically destroys targeted liver tissue, including tumors, at sub-cellular levels and without the use of a scalpel or needle. The device essentially pushes bubbles through human tissue that explode and break apart the tumor.

Instead of developing multiple drugs or devices to target a slew of different types of tumors, the Edison platform could be used for various types of tumors, reducing future research and development costs, the company says.

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