Histotripsy is a noninvasive treatment that destroys tumors with focused ultrasound instead of a scalpel, needle or heat. The device sends very short, high-amplitude ultrasound pulses through the skin to a precise point, creating a “bubble cloud” of microbubbles that rapidly expand and collapse, mechanically breaking the targeted tissue into a cell-free liquid that the body then clears. Yes, it is FDA-authorized for the liver: on October 6, 2023, the FDA granted HistoSonics’ De Novo request (DEN220087) for the Edison System, indicated for the non-invasive destruction of liver tumors, including unresectable ones. In the pivotal study, 95.5% of the 44 treated tumors met the technical-success goal of full tumor coverage on imaging within 36 hours.
Source: U.S. FDA — De Novo decision summary for the HistoSonics Edison System (DEN220087)
Image: Diagram of focused ultrasound targeting a liver tumor through the skin. James Ross McLaughlan via Wikimedia Commons, CC BY-SA 4.0.