On October 9, HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, announced the marketing authorization of its platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous premarket review pathway for medical devices with no existing predicate. The Edison System is indicated for the noninvasive destruction of liver tumors, including unresectable liver tumors, using a nonthermal, mechanical process of focused ultrasound