FDA Awards HistoSonics Clearance of its FirstofaKind Edison Histotripsy System
HistoSonics www.histosonics.com the manufacturer of the Edison System and novel histotripsy therapy platforms announced today the marketing authorization of its Breakthrough platform via the U.S. Food and Drug Administrations FDA De Novo Classification Request process a rigorous premarket review pathway for medical devices with no existing predicate.