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HistoSonics Awarded Key Position in UKs Novel Innovation Program

HistoSonics www.histosonics.com the manufacturer of the Edison System and novel histotripsy therapy platforms announced today that the companys Edison System has been selected to participate in the UKs newly created Innovative Devices Access Pathway IDAP Pilot Program designed to accelerate the development of costeffective medical devices and their integration into the UK market.
United States Ann Arbor United Kingdom Josh King Department Of Health Health Technology Wales

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.
United States Ann Arbor Histosonics Edison Histotripsy Josh King University Of Michigan Drug Administration

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